JP2013006824A - Edible jelly-form composition, jelly-form preparation and method for producing jelly-form preparation - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an edible jelly composition capable of favorably gelling and obtaining a jelly-form preparation by adding a drug-containing solution thereto afterward, and to provide a method for producing the jelly-form formulation.SOLUTION: The edible composition includes a gelling agent and is used for producing the jelly-form preparation by adding the drug-containing solution to be gelatinized.

Description

The present invention relates to an edible composition, a jelly-form preparation that easily gels into a jelly-form preparation by adding a drug-containing solution later, and a method for producing the edible composition.

At present, naked tablets, coated tablets, capsules, powders, granules, liquids and the like are on the market as drugs to be administered orally. As preparations that disintegrate in the oral cavity and are absorbed in the digestive tract, orally disintegrating tablets and fast-dissolving oral film have already been put on the market. Dosage forms that improve the benefits of patients and caregivers taking such attention are attracting attention.
With the increase in the elderly population, there is an increase in the number of so-called chewing / swallowing patients who have difficulty in eating and drinking foods, and semi-solid preparations (jelly, yogurt, Pudding).
Against this background, in recent years, the development of jelly-form preparations containing pharmaceuticals has been promoted, and several types of products have already been sold in Japan.

However, these conventional jelly-form preparations are all gelled with water, and further contain natural polysaccharides as gelling agents and saccharides as additives. Heat sterilization etc. became essential, and there was a problem that addition of preservatives was necessary.
In addition, since it contains a large amount of water, there is a problem that it is difficult to administer to patients who need water restriction such as kidney disease and heart disease. Furthermore, water penetrates the packaging material from the composition. Due to volatilization, there is a problem that an expensive packaging material having high moisture permeability is required for storage stability.

In order to solve such problems, a dry film-form formulation that does not contain water and gelled with saliva includes, for example, a water-swellable gel-forming layer using a cross-linked carboxyvinyl polymer and a drug. A preparation having a content layer (Patent Document 1) is disclosed.
However, such conventional film-shaped preparations require a certain amount of saliva in order to dissolve or swell in the oral cavity using a water-soluble polymer, and depending on the patient who has difficulty in swallowing, it is difficult to dissolve. It could take a long time. In addition, since it easily absorbs moisture, it has a drawback that it easily adheres to the oral mucosa and feels uncomfortable. In particular, in the case of an oral dissolution type film preparation, there is a correlation between the solubility and the thickness and size of the film, and as a result, it was difficult to contain a drug amount exceeding 100 mg.
As for the production method, it is disclosed that such a film-form preparation is prepared by dissolving a water-soluble polymer with water as a solvent, dissolving the drug therein, and drying by heating. In particular, in the case of a drug that is sensitive to heat, there is a concern that the drug content may be reduced by heating. Further, when the drug is in a liquid state, there is a concern that the film-form preparation may be dissolved, so that it may be difficult to maintain a certain shape.

In addition, as a composition which restores jelly by adding water, for example, a dry gel obtained by drying a hydrogel containing native gellan gum (Patent Document 2), a mixture of xanthan gum and locust bean gum, xanthan gum and Disclosed is a dried jelly (Patent Document 3) obtained by lyophilizing a solution obtained by dissolving at least one selected from a mixture with tara gum and cutting the lyophilized jelly into a size of 1 to 3 mm. Yes.
However, with the dry gel disclosed in Patent Document 2, it is difficult to sufficiently restore the jelly-like composition or jelly-form preparation even when water or a drug-containing solution is added. The dried product requires a step of cutting the dried jelly and an operation of stirring the lyophilized jelly after adding water. Risks such as production loss, loss of content, contamination of foreign matter, etc. are considered. There was a disadvantage of lack of convenience.

Japanese Patent No. 4267926 Japanese Patent No. 3671269 Japanese Patent No. 3835544

In view of the present situation, the present invention provides an edible composition that can be suitably gelled to obtain a jelly-form preparation by post-adding a drug-containing solution, a jelly-form preparation using the edible composition, It is an object to provide a method for producing a jelly-form preparation.

As a result of intensive studies to solve the above problems, the present inventors have gelled, preferably gelled in an edible and non-volatile organic solvent to maintain a solid state, and are easily dissolved in water, Alternatively, an edible composition using a gelling agent that easily dissolves at body temperature can be sterilized in the manufacturing process by gelling the gelling agent with a non-volatile organic solvent that is compatible with the gelling agent. It was not necessary to consider, and it was found that by adding a drug-containing solution later, it was possible to easily prepare a jelly-form preparation with good dosage, and the present invention was completed.
Such an edible composition of the present invention is also suitable as a dosage form of a drug that is weak against heat since a drug-containing solution can be added later.
Furthermore, the edible composition of the present invention can be easily made into a jelly-like preparation by simply adding a chemical solution later, even as a drug administration device having different formulations depending on individuals. is there.

That is, the present invention is an edible composition containing a gelling agent, characterized in that it is gelled by adding a drug-containing solution and used to form a jelly-form preparation. is there.
The edible composition of the present invention preferably contains no water, and preferably further contains a nonvolatile organic solvent that is compatible with the gelling agent.
The non-volatile organic solvent is preferably a polyhydric alcohol having 2 to 4 OH groups in the molecule and having 4 or less carbon atoms. Among them, glycerin, glycerin derivatives, propylene glycol, and propylene glycol derivatives It is preferable to include at least one selected from the group consisting of
The gelling agent preferably contains at least one selected from the group consisting of gelatin, κ-carrageenan, HM pectin, native gellan gum, and tamarind gum.

In the edible composition of the present invention, the gelling agent is gelatin, κ-carrageenan, native gellan gum, tamarind gum, ι-carrageenan / sodium carboxymethylcellulose, ι-carrageenan / sodium alginate, ι-carrageenan / xanthan gum. , Ι-carrageenan / λ-carrageenan, ι-carrageenan / deacylated gellan gum, ι-carrageenan / silium seed gum, ι-carrageenan / tragacanth powder, xanthan gum / deacylated gellan gum, xanthan gum / silium seed gum, deacylated gellan gum / Carboxyvinyl polymer, Deacylated gellan gum / LM pectin, Deacylated gellan gum / Sodium alginate, Deacylated gellan gum / λ-carrageenan, Deacylated gela And at least one selected from the group consisting of gum / palladium seed gum, deacylated gellan gum / tragacanth powder, LM pectin / palladium seed gum, and LM pectin / tragacanth powder, and the non-volatile organic solvent includes glycerin and It is preferably a glycerin derivative.

In the edible composition of the present invention, the gelling agent includes at least one selected from the group consisting of gelatin, κ-carrageenan, tamarind gum, and HM pectin, and the nonvolatile organic solvent is Propylene glycol and / or propylene glycol derivatives are preferred.
Further, in the edible composition of the present invention, the nonvolatile organic solvent contains glycerin and / or propylene glycol, and as a solution absorption accelerator, sodium carboxymethylcellulose, LM pectin, sodium alginate, xanthan gum, iota-carrageenan, λ -It preferably contains at least one selected from the group consisting of carrageenan, deacylated gellan gum, psyllium seed gum, and tragacanth powder.

Moreover, this invention is also a jelly-form preparation characterized by being obtained by adding a drug containing solution to the edible composition of this invention.
The drug-containing solution is preferably an injection solution or an oral solution. In addition, the solvent contained in the drug-containing solution is preferably at least one selected from the group consisting of water, glycerin, and propylene glycol.
Moreover, it is preferable that the compounding quantity of the said gelatinizer is 0.1 to 40 weight% on the basis of the total weight of a jelly-form preparation.
The edible composition contains a nonvolatile organic solvent that is compatible with the gelling agent, and the amount of the nonvolatile organic solvent is 10 to 99% by weight based on the total weight of the jelly-form preparation. Is preferred.

The present invention also includes a step of mixing, heating and dissolving water, a gelling agent and a non-volatile organic solvent compatible with the gelling agent to obtain a non-volatile organic solvent-containing gelling agent solution, A step of dispensing or stretching a gelling organic solvent-containing gelling agent solution, a step of solidifying by cooling or cooling to obtain an edible composition, and adding a drug-containing solution to the edible composition to form a jelly It is also a method for producing a jelly-form preparation characterized by having a step of obtaining a preparation.
The present invention also includes a step of mixing, heating, and dissolving water and a gelling agent to obtain a gelling agent solution, a step of freeze-drying the gelling agent solution to obtain a readily soluble gelling agent, A step of obtaining a non-volatile organic solvent-containing gelling agent solution by mixing, heating, and dissolving a non-volatile organic solvent that is compatible with the easily-soluble gelling agent in the readily soluble gelling agent, containing the non-volatile organic solvent A step of dispensing or stretching the gelling agent solution, a step of solidifying by cooling or cooling to obtain an edible composition, and a step of adding a drug-containing solution to the edible composition to obtain a jelly-form preparation It is also a manufacturing method of the jelly-form preparation characterized by having.
Hereinafter, the present invention will be described in detail.

The present invention is an edible composition containing a gelling agent, which is used for gelation by adding a drug-containing solution to obtain a jelly-form preparation.
The shape of the edible composition of the present invention is not particularly limited, but a larger surface area is preferable from the viewpoint that a drug-containing solution added later easily infiltrates and becomes uniform. In addition, it depends particularly on the size of the jelly-like preparation after the drug-containing solution is added.
The optimal shape of the size of the jelly-like preparation obtained using the edible composition of the present invention varies depending on the jelly strength and the intended use. For example, when it is used as a jelly-form preparation taken by a patient or a cared person, it is preferable that the jelly-form composition has sufficient strength to be self-supporting and is in the form of a tablet, film or sheet. In particular, from the viewpoint of solubility in the oral cavity, a film and a sheet-like shape are preferable, and in this case, the thickness is preferably 30 to 5000 μm. If the thickness is less than 30 μm, there is a possibility of a problem from the viewpoint of the film strength and the handleability of the product. If the thickness exceeds 5000 μm, there is a risk of feeling uncomfortable when administered into the oral cavity, particularly under the tongue.

The size of the jelly-form preparation obtained by using the edible composition of the present invention is not particularly limited when used as a sheet-form preparation, but the plane area is in the range of 0.5 to 6.0 cm ² . Is preferred. If it is less than 0.5 cm ² , it may be difficult to handle when the preparation is picked and administered. If it exceeds 6.0 cm ² , it should be completely put into the oral cavity, especially when sublingually. There is a risk of not being able to.
The planar shape of the sheet-shaped preparation is not particularly limited, and examples thereof include an arbitrary shape such as a rectangle such as a rectangle and a square, a polygon such as a pentagon, a circle and an ellipse. The polygon referred to here includes not only a perfect polygon but also a shape having R at the corners.
If the patient cannot take the medicine by himself / herself and is administered by a healthcare worker or caregiver, the shape of the cup packaging or pillow packaging that can soften the strength of the jelly-form preparation and assist the administration with a spoon or the like is also available. preferable.

The said gelatinizer is a material used as the base material of the edible composition of this invention.
Such a gelling agent is not particularly limited as long as it is edible and has gelling ability, but gelatin, κ-carrageenan, HM pectin, native gellan gum from the viewpoint of compatibility with the nonvolatile organic solvent described later. And at least one selected from the group consisting of tamarind gum is preferably used.
By including the κ-carrageenan and the like as the gelling agent, the edible composition of the present invention can be gelled in a non-volatile organic solvent and can be easily dissolved in water.
In the present specification, “edible” means that it can be administered orally and is pharmaceutically acceptable.

Here, carrageenan is a kind of linear sulfur-containing polysaccharide, generally obtained by alkaline extraction from Chondrus cripus (red algae), D-galactose, 3,6-anhydro-D-galactose, and It is an anionic polymer compound composed of a sulfate group. These components are divided into κ-carrageenan, ι-carrageenan and λ-carrageenan, respectively.
In the present invention, κ-carrageenan is preferable from the viewpoint of gelation in a non-volatile organic solvent and further gelation after addition of water. In the case of ι-carrageenan, it does not gel by itself and requires Ca ²⁺ or the like separately.
The above-mentioned κ-carrageenan has a gel point in the presence of a non-volatile organic solvent that is compatible with the κ-carrageenan, which is around 80 ° C. Therefore, the physical properties near room temperature are stable, from the viewpoint of storage in use. Is also excellent.
In addition, even when a heat-sensitive drug (drug having low heat stability) is used as the drug contained in the drug-containing solution, the drug-containing solution can be added to the edible composition of the present invention to add heat stability. Therefore, it is possible to ensure the stability at the time of producing a low-drug drug.
Among these κ-carrageenans, grades having an average molecular weight of 50,000 to 500,000 are preferred, and grades containing K ⁺ , Ca ²⁺ and Na ⁺ as counter cations are preferred. More preferably, a grade containing Na ⁺ as a counter ion is preferred from the viewpoint of solubility.
The average molecular weight here means a weight average molecular weight, and is measured by gel filtration chromatography analysis.

Pectin is a high-molecular polysaccharide obtained by extracting water from edible plants, generally citrus fruits or apples, and is composed of galacturonic acid, with the carboxyl group partially methyl esterified. ing.
Of the galacturonic acids, 50% or more of the pectin is divided into HM pectin and less than 50% is LM pectin, depending on the proportion of methylated galacturonic acid. The degree of esterification (DE) of pectin is the number of esterified carboxyl groups per 100 equivalents of galacturonic acid. The galacturonic acid content (GA) is the weight of galacturonic acid (molecular weight 194.1) per 100 g of the roughly purified sample. These measurements are performed in the above two steps: (1) measurement of free acid amount by titration, (2) measurement of free acid amount after saponification by titration.
In the edible composition of the present invention, HM pectin is preferable from the viewpoint of gelation in a non-volatile organic solvent and further gelation after addition of water.
The above HM pectin has a gel point in the presence of a non-volatile organic solvent compatible with the HM pectin at around 70 ° C., so that the physical properties near room temperature are stable, and it is excellent from the viewpoint of storage in use. ing.
In addition, even when a heat-sensitive drug (drug having low heat stability) is used as the drug contained in the drug-containing solution, the drug-containing solution can be added to the edible composition of the present invention to add heat stability. Therefore, it is possible to prepare a jelly-form preparation while ensuring the stability during the production of a low-drug drug.
Among these HM pectin, grades having an average molecular weight of 10,000 to 150,000 are preferable.
The average molecular weight here means a weight average molecular weight, and is measured by gel filtration chromatography analysis.

Gellan gum is a natural linear heteropolysaccharide produced outside the cells of the microorganism Sphingomonas erodea, and is composed of repeating units of tetrasaccharides of glucose, glucuronic acid, glucose and rhamnose. Yes.
The gellan gum is classified into native gellan gum and deacylated gellan gum depending on the presence or absence of acetyl and glyceryl groups present in 1-3-bound glucose. In the edible composition of the present invention, native gellan gum is preferable from the viewpoint of gelation in a non-volatile organic solvent and further gelation after addition of water.
The native gellan gum has a gel point in the presence of a non-volatile organic solvent that is compatible with the native gellan gum, which is around 90 ° C. Therefore, the physical properties near room temperature are stable, and from the viewpoint of storage for use. Is also excellent.
In addition, even when a heat-sensitive drug (drug having low heat stability) is used as the drug contained in the drug-containing solution, the drug-containing solution can be added to the edible composition of the present invention to add heat stability. Therefore, it is possible to prepare a jelly-form preparation while ensuring the stability during the production of a low-drug drug.
Among these native gellan gums, grades having an average molecular weight of 100,000 to 700,000 are preferable.
The average molecular weight here means a weight average molecular weight, and is measured by gel filtration chromatography analysis.

The tamarind gum is a high molecular polysaccharide obtained by extracting the endosperm portion of the seed of tamarind, which is a leguminous plant, with warm water or an alkaline aqueous solution, the main chain is glucose, the side chain is xylose or xylose and It is composed of galactose.
The tamarind gum has a gel point in the presence of a non-volatile organic solvent that is compatible with the tamarind gum, which is around 80 ° C. Therefore, the physical properties near room temperature are stable, and it is excellent from the viewpoint of storage in use. ing.
Further, even when using a drug that is weak against heat (drug having low heat stability) as the drug contained in the drug-containing solution, by adding the drug-containing solution to the edible jelly-like composition of the present invention, Stability at the time of manufacture of a drug with low stability can also be secured.
Among these tamarind gums, those having an average molecular weight of 100,000 to 700,000 are preferable.
The average molecular weight here means a weight average molecular weight, and is measured by gel filtration chromatography analysis.

The gelatin is a protein obtained by decomposing and extracting proteins contained in animal skin and bone with an enzyme, and any of those obtained by acid treatment and alkali treatment of pork, cow and fish-derived materials can be used.
As the gelatin, fish or pig-derived gelatin is preferable from the viewpoint of problems such as BSE.
Among these gelatins, those having an average molecular weight of 50,000 to 120,000 are preferable. The average molecular weight here means a weight average molecular weight, and is measured by gel filtration chromatography analysis.
Moreover, the average molecular weight here means not the molecular weight of the polypeptide chain trimer of gelatin but the molecular weight of each polypeptide chain monomer.

In the edible composition of the present invention, the content of the gelling agent is preferably 0.1 to 40% by weight, more preferably 0.5 to 30%, based on the total weight of the edible composition of the present invention. % By weight, more preferably 1 to 20% by weight. If it is less than 0.1% by weight, gelation may not occur at room temperature. On the other hand, if it exceeds 40% by weight, the solubility in the oral cavity becomes extremely slow, which may cause a problem in use.

The edible composition of the present invention includes, in addition to at least one selected from the group consisting of gelatin, κ-carrageenan, HM pectin, native gellan gum, and tamarind gum suitable as the gelling agent. As long as the effect is not inhibited, other edible polymers can be used in combination.

Examples of the other edible polymers include polyethylene glycol, polyvinyl alcohol, carboxyvinyl polymer, hydroxypropylmethylcellulose, hydroxyethylcellulose, methylcellulose, ethylcellulose, low-substituted hydroxypropylcellulose, crystalline cellulose, carboxymethylcellulose sodium, carboxymethylcellulose calcium. , Synthetic polymer compounds such as carboxymethylcellulose, sodium carboxymethyl starch, dextran, casein, guar gum, tragacanth gum, acacia gum, gum arabic, psyllium seed gum, starch, zein, xanthan gum, locust bean gum, LM pectin, deacylated gellan gum , Tara gum, sodium alginate, agar, etc. Polymeric compounds obtained from natural products thereof. The amount of the other edible polymer is preferably 0.1 to 10% by weight based on the total weight of the edible composition of the present invention.

Furthermore, although the edible composition of the present invention does not become a gelling agent as a simple substance as the gelling agent, a material that can become a gelling agent by combining two types may be used. Examples of such two kinds of combinations include ι-carrageenan / carboxymethylcellulose sodium, ι-carrageenan / sodium alginate, ι-carrageenan / xanthan gum, ι-carrageenan / λ-carrageenan, ι-carrageenan / deacylated gellan gum, ι-Carrageenan / Psyllium seed gum, ι-Carrageenan / Tragant powder, Xanthan gum / Deacylated gellan gum, Xanthan gum / Psyllium seed gum, Deacylated gellan gum / Carboxyvinyl polymer, Deacylated gellan gum / LM pectin, Deacylated gellan gum / Sodium alginate, deacylated gellan gum / λ-carrageenan, deacylated gellan gum / silium seed gum, deacylated gellan gum / tragacanth powder, LM Preferably contains at least one combination selected from the group consisting of on / psyllium seed gum and LM pectins / powdered tragacanth.

Among them, in the edible composition of the present invention, the gelling agent includes gelatin, κ-carrageenan, native gellan gum, tamarind gum, ι-carrageenan / carboxymethylcellulose sodium, ι-carrageenan / sodium alginate, ι-carrageenan / Xanthan gum, ι-carrageenan / λ-carrageenan, ι-carrageenan / deacylated gellan gum, ι-carrageenan / palladium seed gum, ι-carrageenan / tragacanth powder, xanthan gum / deacylated gellan gum, xanthan gum / palladium seed gum, deacylated Gellan gum / carboxyvinyl polymer, deacylated gellan gum / LM pectin, deacylated gellan gum / sodium alginate, deacylated gellan gum / λ-carrageenan, deacylated gellan A non-volatile organic solvent, which is described later, is glycerin, including at least one selected from the group consisting of mu / palladium seed gum, deacylated gellan gum / tragacanth powder, LM pectin / palladium seed gum, and LM pectin / tragacanth powder. And / or a glycerin derivative.
Furthermore, in the edible composition of the present invention, the gelling agent contains at least one selected from the group consisting of gelatin, κ-carrageenan, tamarind gum, and HM pectin, and the nonvolatile organic solvent described later is , Propylene glycol and / or propylene glycol derivatives are preferred. In addition, since it will aggregate if it uses a basic gelling agent and an acidic gelling agent in combination as said gelling agent, it is unpreferable.

The edible composition of the present invention preferably further contains a nonvolatile organic solvent that is compatible with the gelling agent.
The non-volatile organic solvent has an action of assisting dissolution of the jelly-form preparation obtained using the edible composition of the present invention. That is, by controlling the content of the nonvolatile organic solvent in the edible composition of the present invention, the dissolution time of the jelly-form preparation obtained using the edible composition of the present invention can be easily controlled. .
Therefore, the jelly-like preparation obtained by using the edible composition of the present invention is dissolved both in the oral cavity and taken slowly in the oral cavity, particularly under the tongue, and the drug is subtracted. Suitable.
The content of the nonvolatile organic solvent is preferably 10 to 99% by weight, more preferably 20 to 80% by weight, based on the total weight of the jelly-form preparation obtained using the edible composition of the present invention. is there. If it is less than 10% by weight, the solubility in the oral cavity becomes extremely poor, which may cause a problem in use. On the other hand, if it exceeds 99% by weight, storage of physical properties such as shape retention at room temperature is possible. There is a risk of poor stability.

The nonvolatile organic solvent is not particularly limited as long as it is compatible with the gelling agent and is edible, but a polyhydric alcohol having 2 to 4 OH groups in the molecule and having 4 or less carbon atoms is preferable. Used for.
When the number of OH groups in the polyhydric alcohol molecule is less than 2, the compatibility with the gelling agent may be deteriorated. On the other hand, when the number of OH groups in the polyhydric alcohol molecule exceeds 4, The melting point rises and becomes a solid at room temperature, which may make it difficult to use as a solvent.
Moreover, when carbon number of the said polyhydric alcohol exceeds 4, compatibility with a gelatinizer may worsen.

Suitable examples of such polyhydric alcohols include at least one selected from the group consisting of glycerin, glycerin derivatives, propylene glycol, propylene glycol derivatives, ethylene glycol, and ethylene glycol derivatives.
Such nonvolatile organic solvents are used alone or in combination of two or more. Among them, when included in a large amount in the edible composition of the present invention, glycerin and / or propylene glycol are preferable from the viewpoint of safety for administration to humans when a jelly-form preparation is obtained.
When the edible composition of the present invention contains glycerin and / or propylene glycol as the non-volatile organic solvent, for the purpose of increasing the absorption rate of the non-volatile organic solvent, It is preferable to include at least one selected from the group consisting of LM pectin, sodium alginate, xanthan gum, ι-carrageenan, λ-carrageenan, deacylated gellan gum, psyllium seed gum, and tragacanth powder.

Moreover, it is preferable that the edible composition of this invention does not contain water.
By not containing the above water, the edible composition of the present invention does not require a sterilization step or addition of a preservative necessary for production in a general edible jelly-like composition, and has an advantage in terms of production cost. It is also suitable when applied to dietary supplements and pharmaceutical dosage forms for patients who need water restriction.
In the present specification, “not including water” includes a case where substantially no water is included. For example, the water content is 5 wt% or less based on the total weight of the edible composition of the present invention, It means preferably 2.5% by weight or less, more preferably 1% by weight or less.

The edible composition of the present invention may contain an antifoaming agent.
Examples of the antifoaming agent include sorbitan fatty acid esters and sucrose fatty acid esters.
Examples of the sorbitan fatty acid ester include sorbitan monooleate, sorbitan trioleate, sorbitan sesquioleate, coconut oil fatty acid sorbitan, polyoxyethylene sorbitan fatty acid ester, and the like.
Examples of the sucrose fatty acid ester include sucrose stearate, sucrose oleate, sucrose palmitate, sucrose myristic ester, sucrose behenate, sucrose erucate, and sucrose. Examples include mixed fatty acid esters.

In addition, the edible composition of the present invention includes, as a component constituting the base material of the edible composition, in addition to the above substances, if necessary, a flavoring agent, a flavoring agent, a sweetening agent, a coloring agent, a preservative, and an antioxidant. Agents, stabilizers, surfactants and the like may be used as appropriate.

The edible composition of this invention may contain the additive which improves a physical property and solubility.
Examples of the additive include monosaccharides, disaccharides, tri-hexasaccharide sugars and sugar alcohols thereof as shown below.
Examples of monosaccharides include aldoterose such as erythrose and throse, aldpentose such as ribose, lyxose, xylose and arabinose, aldohexose such as allose, talose, gulose, glucose, altrose, mannose, galactose and idose, and erythrose. Examples include keto tetroses such as roulose, ketopentoses such as xylulose and ribulose, ketohexoses such as psicose, fructose, sorbose and tagatose. Examples of the disaccharide include α-diglucoside such as trehalose, cordobiose, nigerose, maltose, isomaltose, β-diglucoside such as isotrehalose, sophorose, laminaribiose, cellobiose, gentiobiose, α, β-diglucoside such as neotrehalose. In addition, lactose, sucrose, isomaltulose (palatinose) and the like can be mentioned. Examples of the trisaccharide include raffinose. Examples of trisaccharide to hexasaccharide oligosaccharides include fructooligosaccharides, galactooligosaccharides, xylo-oligosaccharides, isomaltoligosaccharides, chitin oligosaccharides, chitosan oligosaccharides, oligosaccharides such as oligoglucosamine, dextrin and cyclodextrin. .

Examples of monosaccharide alcohols include tetritols such as erythritol, D-threitol, and L-threitol, pentitols such as D-arabinitol and xylitol, D-iditol, galactitol (dulcitol), and D-glucitol (sorbitol). Hexitol such as mannitol, cyclitol such as inositol, and the like. Examples of the disaccharide alcohol include maltitol, lactitol, and reduced palatinose (isomalt). Examples of the oligosaccharide alcohol include pentaerythritol and reduced maltose starch syrup.
In the edible composition of the present invention, the sugar or sugar alcohol may be substituted, or one kind or a mixture of two or more kinds may be used.

The sugar or sugar alcohol is a monosaccharide from the viewpoint that the sheet-like jelly-form preparation using the edible composition of the present invention is easily dissolved in the oral cavity and that the viscosity of the solution is not greatly changed in the production process. It is preferably a trisaccharide or a sugar alcohol thereof.

The amount of such additives is preferably 1-80% by weight, more preferably 5-70% by weight, based on the total weight of the edible composition of the present invention. If it is less than 1% by weight, there is a possibility that sufficient physical properties for use may not be ensured. On the other hand, if it exceeds 80% by weight, the edible composition of the present invention is added to the sheet or film-shaped jelly by the added additive. When used as a solid preparation, control of physical properties may be difficult.

The edible composition of the present invention can provide a jelly-form preparation by post-adding a drug-containing solution.
In the present specification, the drug means a substance having some physiological activity. A jelly-like preparation obtained by adding a drug-containing solution to the edible composition of the present invention is also one aspect of the present invention.

In the jelly-form preparation of the present invention, the drug is preferably a drug that can be administered to a mammal such as a human through its sublingual, oral, or intestinal tract, that is, orally administrable. Specific examples of such drugs include general anesthetics, hypnotics / sedatives, antiepileptics, antipyretic analgesic / anti-inflammatory drugs, antipruritics, neuropsychiatric drugs, central nervous system drugs, anti-dementia drugs, topical drugs Anesthetics, skeletal muscle relaxants, autonomic drugs, antispasmodics, antiparkinson drugs, antihistamines, cardiotonic drugs, arrhythmic drugs, diuretics, antihypertensive drugs, vasoconstrictors, coronary vasodilators, peripheral vasodilators Drugs, arteriosclerotic drugs, cardiovascular drugs, respiratory stimulants, antitussive expectorants, hormonal drugs, suppurative diseases topical drugs, analgesic / antipruritic / convergence / anti-inflammatory drugs, parasitic skin disease drugs, hemostatic drugs, Examples include drugs for treating gout, drugs for diabetes, drugs for antineoplastic tumors, antibiotics, chemotherapeutic drugs, narcotics, smoking cessation aids, allergens for desensitization therapy, and vaccines.

The drug should also be present in the adhesive layer in an amount, also referred to herein as an effective amount, sufficient to produce a desired result in the treatment of a disease, condition or disorder, for example, the desired therapeutic result. Can do.
An effective amount of drug means, for example, an amount of the drug that is non-toxic but sufficient to produce a selected effect over a specified period of time. Such an amount can be readily determined by one skilled in the art.

The drug may be a solid drug or a liquid drug. The solid drug here means a drug that is solid at room temperature (25 ° C.), that is, a drug having a melting point higher than 25 ° C. The melting point here means a value measured by DSC, model number DSC6220 (manufactured by Seiko Instruments (SII)).
The liquid drug means a drug having fluidity at room temperature (25 ° C.), that is, a drug having a viscosity of 0.05 to 100,000 mPa · s. The viscosity of the drug is measured using an E-type viscometer while keeping the drug at 25 ° C.
The drug-containing solution containing such a drug is preferably an injection solution or an oral solution.

The concentration of the drug is usually 1 × 10 ⁻¹⁰ to 80% by weight with respect to the total weight of the jelly-form preparation of the present invention, although it varies depending on the nature and the like. If it is less than 1 × 10 ⁻¹⁰ wt%, there are cases where the drug efficacy is not shown in many drugs from the viewpoint of clinical effect, and if it exceeds 80 wt%, the physical properties of the jelly preparation are remarkably lowered. There may be a problem with the shape retention.

In addition, the solvent contained in the drug-containing solution is preferably at least one selected from the group consisting of water, glycerin, and propylene glycol from the viewpoint of safety for administration to humans.

In the jelly-like preparation of the present invention, the amount of the gelling agent is preferably 0.1 to 40% by weight, more preferably 0.5 to 30% by weight, based on the total weight of the jelly-like preparation. Preferably, it is 1 to 20% by weight. If it is less than 0.1% by weight, gelation may not occur at room temperature. On the other hand, if it exceeds 40% by weight, the solubility in the oral cavity becomes extremely slow, which may cause a problem in use.

Moreover, in the jelly-form preparation of the present invention, the edible composition of the present invention described above contains a non-volatile organic solvent that is compatible with the gelling agent, and the blending amount of the non-volatile organic solvent is that of the jelly-form preparation. It is preferably 10 to 99% by weight, more preferably 20 to 80% by weight based on the total weight. If the non-volatile organic solvent is less than 10% by weight, the solubility in the oral cavity becomes extremely poor, which may cause a problem in use. On the other hand, if it exceeds 99% by weight, the shape retention at room temperature, etc. There is a risk that the storage stability of the physical properties of the product will deteriorate.

Moreover, in the jelly-form preparation of the present invention, it is preferable that the gelling agent and the non-volatile organic solvent are appropriately selected and used in combination so as to achieve the effects of the present invention.
As a preferable combination of the gelling agent and the non-volatile organic solvent in the present invention, for example, the gelling agent is at least one selected from the group consisting of gelatin, κ-carrageenan, native gellan gum, and tamarind gum. Examples of the nonvolatile organic solvent that is a seed and is compatible with the gelling agent include a combination of glycerin and / or a glycerin derivative.
As another combination, for example, the gelling agent is at least one selected from the group consisting of gelatin, κ-carrageenan, tamarind gum, and HM pectin, and is a non-volatile material compatible with the gelling agent. Examples of the organic solvent include a combination of propylene glycol and / or a propylene glycol derivative.

The jelly-form preparation of the present invention is obtained by mixing, heating, and dissolving water, a gelling agent, and a non-volatile organic solvent compatible with the gelling agent to obtain a non-volatile organic solvent-containing gelling agent solution, for example. A step of dispensing or stretching the non-volatile organic solvent-containing gelling agent solution, a step of solidifying by cooling or cooling to obtain an edible composition, and adding a drug-containing solution to the edible composition And it can manufacture by the method including the process of obtaining a jelly-form preparation.
Such a method for producing the jelly-form preparation of the present invention is also one aspect of the present invention.
In addition, in the manufacturing method of the jelly-form preparation of this invention, the edible composition of this invention can be manufactured by performing even the process of obtaining the said edible composition.

In the step of obtaining the non-volatile organic solvent-containing gelling agent solution, first, a gelling agent such as κ-carrageenan, xanthan gum, pectin, gellan gum, tamarind gum, and other additives are added to a predetermined amount of non-volatile organic solvent. Additives that are dissolved at room temperature or by heating and are not dissolved in the non-volatile organic solvent are uniformly dispersed.
Here, when foam is generated during the preparation of the non-volatile organic solvent-containing gelling agent solution, the foam is sufficiently defoamed by standing for a long time or performing vacuum or vacuum degassing.
The step of obtaining the non-volatile organic solvent-containing gelling solution includes a step of mixing, heating and dissolving water and a gelling agent in advance to obtain a gelling agent solution, and freeze-drying the gelling agent solution. The step of obtaining a readily soluble gelling agent is performed, and the easily soluble gelling agent is mixed with a nonvolatile organic solvent that is compatible with the easily soluble gelling agent, heated and dissolved to contain a nonvolatile organic solvent. It may be a step of obtaining a gelling agent solution. By performing such a step, the gelling agent can be dissolved in the nonvolatile organic solvent even if it is not easily dissolved in the nonvolatile organic solvent. The method for producing a jelly-form preparation having a step of obtaining such a gelling agent solution and a step of obtaining a readily soluble gelling agent before the step of obtaining a non-volatile organic solvent-containing gelling solution is also another aspect. This is one of the present inventions.

In the step of dispensing or stretching the non-volatile organic solvent-containing gelling agent solution and the step of solidifying by cooling or cooling, a predetermined amount of the non-volatile organic solvent-containing gelling agent solution is set to a temperature of 40 to 80 ° C. Dispense into a plastic or aluminum blister case and pillow package of the desired size below and cool and solidify immediately after dispensing to obtain an edible composition. Instead of the dispensing method, an appropriate amount of the non-volatile organic solvent-containing gelling agent solution may be spread on a plastic release film, cooled and solidified, and cut into a desired size.

In addition, in order to remove the water added to the said non-volatile organic-solvent containing gelatinizer solution, it is necessary to perform heat drying or reduced pressure drying before making it cool and solidify in this process.
Moreover, when preparing content of the non-volatile organic solvent contained in the jelly-form preparation to manufacture, you may perform a cold-air drying process or a cooling pressure reduction drying process after this process.

In the step of obtaining the jelly-form preparation, the drug-containing solution is infiltrated into the edible composition by applying the drug-containing solution described above to the edible composition.
Thus, since the drug-containing solution is added after the edible composition is formed, even the heat-labile drug can be suitably used in the method for producing a jelly-form preparation of the present invention.

The obtained sheet or film-like jelly-form preparation is preferably sealed and packaged as necessary to obtain a product. In particular, since the jelly-form preparation does not contain water, a sterilization step such as a heat sterilization step that is generally required is unnecessary, which is convenient.

The edible composition of the present invention can be suitably gelled to obtain a jelly-form preparation by post-adding the drug-containing solution, and the jelly-form preparation after addition of the drug-containing solution dissolves in the oral cavity. It can be. Moreover, since the edible composition of this invention does not contain water suitably and contains a non-volatile organic solvent, it is not necessary to consider the sterilization in a manufacturing process, and is suitable as a dosage form of a heat-sensitive drug.
More specifically, the edible composition of the present invention is preferably a water-free jelly-like composition, and comprises gelatin, κ-carrageenan, tamarind gum, and HM pectin as gelling agents. By using at least one selected from the group, it has a characteristic of gelling at room temperature and easily dissolved in saliva in the oral cavity.
Moreover, the edible composition of this invention can also control the dissolution time easily by controlling content of a non-volatile organic solvent. From the viewpoint that the dissolution time can be controlled, as a pharmaceutical dosage form that is absorbed from the oral mucosa and sublingual mucosa that require residence time in the oral cavity, for example, sensitize allergen from the sublingual mucosa. Suitable for sublingual desensitization therapy.
In addition, from the viewpoint of not containing water, the edible composition of the present invention does not require the addition of a sterilization step or preservative necessary for general jelly, and has an advantage in terms of production cost, It is also suitable as a dietary supplement and pharmaceutical dosage form for patients who need water restriction.
The jelly-like preparation obtained by using the edible composition of the present invention is generally known to improve storage stability of proteins and peptides, such as gelatin, polysaccharides and polyols such as glycerin and propylene glycol. Since it is suitably used, it is expected that a protein or peptide can be particularly maintained stably.
Of course, the jelly-form preparation of the present invention may be swallowed as it is, or may be swallowed after rapidly dissolving in the oral cavity. Furthermore, it is possible to expect the absorption from the oral mucosa and the sublingual mucosa by controlling the dissolution time in the oral cavity. Since it can be completely dissolved at body temperature, from the viewpoint that there is no residue feeling and that it does not contain water, the jelly-form preparation of the present invention has a QOL for patients with limited water, patients with difficulty swallowing, and caregivers. It can be greatly improved.

The present invention will be specifically described by the following examples, but the present invention is not limited to these examples.

Example 1
4.0 parts by weight of purified water (Japanese Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 40 ° C., and 2.0 parts by weight of fish-derived water-soluble gelatin (water-soluble gelatin CSF, manufactured by Nippi) is added. After sufficiently stirring and dissolving, 4.0 parts by weight of propylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed at a temperature of 40 ° C. with stirring. After mixing, 1.0 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Example 2)
4.0 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 60 ° C., and 2.0 parts by weight of porcine-derived low molecular gelatin (pig bone gelatin AEP, manufactured by Nippi) is added. After sufficiently stirring and dissolving, 4.0 parts by weight of propylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed at a temperature of 60 ° C. with stirring. After mixing, 1.0 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 3 to 5)
According to the composition shown in Table 1, an edible composition was prepared in the same procedure as in Example 2. Instead of pork-derived low molecular gelatin, pig-derived acid-treated gelatin (AP-200F, manufactured by Nippi) was used in Example 3, and pig-derived alkali-treated gelatin (BP-200F, manufactured by Nippi) was used in Example 4. Then, cow-derived alkali-treated gelatin (AD4, manufactured by Nippi) was used.

(Example 6)
Purified water (Japanese Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) 8.0 parts by weight was heated to 85 ° C. and κ-carrageenan (GENUGEL JPE-126, CP Kelco Co., Ltd.) 0.4 parts by weight was added. After sufficiently stirring and dissolving, 3.6 parts by weight of propylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed while stirring at a temperature of 85 ° C. After mixing, 1.8 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 7 and 8)
According to the composition shown in Table 1, an edible composition was prepared in the same procedure as in Example 6. In place of κ-carrageenan, tamarind gum (Glyroid 3S, manufactured by DSP Gokyo Food & Chemical) was used in Example 7, and HM pectin (GENU PECTIN Type USP-H, manufactured by CP Kelco) was used in Example 8.

(Comparative Example 1)
8.0 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical) is heated to 85 ° C., and 0.4 part by weight of LM pectin (GENU PECTIN Type LM-102AS-J, CP Kelco) is added. After sufficiently stirring and dissolving, 3.6 parts by weight of propylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed while stirring at a temperature of 85 ° C. After mixing, 1.8 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Comparative Examples 2 to 5)
According to the composition shown in Table 1, an edible composition was prepared in the same procedure as in Comparative Example 1. Instead of LM pectin, tara gum (MT120, manufactured by MRC polysaccharides) is used in comparative example 2, locust bean gum (GENUGUM RL-200-J, CP Kelco) is used in comparative example 3, and xanthan gum (labor gum GS is used in comparative example 4). -C, DSP Gokyo Food & Chemical Co., Ltd.) and Comparative Example 5 used deacylated gellan gum (Kelco Gel, CP Kelco Co.).

Example 9
4.0 parts by weight of purified water (Japanese Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 40 ° C., and 2.0 parts by weight of fish-derived water-soluble gelatin (water-soluble gelatin CSF, manufactured by Nippi) is added. After fully stirring and dissolving, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed while stirring at a temperature of 40 ° C. After mixing, 1.0 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Example 10)
4.0 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 60 ° C., and 2.0 parts by weight of porcine-derived low molecular gelatin (pig bone gelatin AEP, manufactured by Nippi) is added. After sufficiently stirring and dissolving, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed while stirring at a temperature of 60 ° C. After mixing, 1.0 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 11 to 13)
According to the composition shown in Table 2, an edible composition was prepared in the same procedure as in Example 10. In place of pig-derived low molecular gelatin, pig-derived acid-treated gelatin (AP-200F, manufactured by Nippi) was used in Example 11, and pig-derived alkali-processed gelatin (BP-200F, manufactured by Nippi) was used in Example 12. Then, cow-derived alkali-treated gelatin (AD4, manufactured by Nippi) was used.

(Example 14)
Purified water (Japanese Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) 8.0 parts by weight was heated to 85 ° C. and κ-carrageenan (GENUGEL JPE-126, CP Kelco Co., Ltd.) 0.4 parts by weight was added. After sufficiently stirring and dissolving, 3.6 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed while stirring at a temperature of 85 ° C. After mixing, 1.8 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 15 and 16)
According to the composition shown in Table 2, an edible composition was prepared in the same procedure as in Example 14. Instead of κ-carrageenan, native gellan gum (Kelcogel LT100, CP Kelco) was used in Example 15, and tamarind gum (Glyroid 3S, DSP Gokyo Food & Chemical) was used in Example 16.

(Comparative Example 6)
Purified water (Japanese Pharmacopoeia purified water, Kenei Pharmaceutical Co., Ltd.) 8.0 parts by weight is heated to 85 ° C., and LM pectin (GENU PECTIN Type LM-102AS-J, CP Kelco Co., Ltd.) 0.4 parts by weight. After sufficiently stirring and dissolving, 3.6 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed while stirring at a temperature of 85 ° C. After mixing, 1.8 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Comparative Examples 7 to 10)
According to the composition shown in Table 2, an edible composition was prepared in the same procedure as in Comparative Example 6. In place of LM pectin, tara gum (MT120, manufactured by MRC Polysaccharide) was used in Comparative Example 7, locust bean gum (GENUGUM RL-200-J, CP Kelco) was used in Comparative Example 8, and xanthan gum (Labor Gum GS was used in Comparative Example 9). -C, DSP Gokyo Food & Chemical Co.) and Comparative Example 10 used deacylated gellan gum (Kelcogel, CP Kelco).

(Example 17)
5.0 parts by weight of fish-derived water-soluble gelatin (water-soluble gelatin CSF, manufactured by Nippi) is dissolved in 1000 parts by weight of purified water (Japanese Pharmacopoeia purified water, Kennaga Pharmaceutical Co., Ltd.) at 40 ° C. and released at room temperature. After cooling, it was frozen with liquid nitrogen, and freeze-dried for one day and night with a freeze dryer (DC400, manufactured by Yamato Scientific Co., Ltd.). After sufficiently stirring 2.0 parts by weight of fish-derived water-soluble gelatin (FD product) that has been freeze-dried, 6.0 parts by weight of propylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.) is added at a temperature of 60 ° C. It was dissolved with stirring. After dissolution, 0.6 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech Co., Ltd.) and allowed to cool at room temperature to obtain an edible composition.

(Example 18)
Purified water (Japanese Pharmacopoeia purified water, manufactured by Kennaga Pharmaceutical Co., Ltd.) 1000 parts by weight, pork-derived low molecular gelatin (pig bone gelatin AEP, manufactured by Nippi Co., Ltd.) 5.0 parts by weight at 60 ° C. and dissolved at room temperature. After cooling, it was frozen with liquid nitrogen, and freeze-dried for one day and night with a freeze dryer (DC400, manufactured by Yamato Scientific Co., Ltd.). After sufficiently stirring 2.0 parts by weight of pork-derived low molecular weight gelatin (FD product) that has been freeze-dried, 6.0 parts by weight of propylene glycol (manufactured by Wako Pure Chemical Industries, Ltd.) is added, and the temperature is 60 ° C. It was dissolved with stirring. After dissolution, 0.6 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech Co., Ltd.) and allowed to cool at room temperature to obtain an edible composition.

(Examples 19 to 21)
According to the composition shown in Table 3, the edible composition was prepared in the same procedure as in Example 18. In place of pork-derived low molecular gelatin, pig-derived acid-treated gelatin (FD product) (AP-200F, manufactured by Nippi) in Example 19, and pig-derived alkali-treated gelatin (FD product) (BP-200F, in Example 20) In Example 21, cattle-derived alkali-treated gelatin (FD product) (AD4, manufactured by Nippi) was used.

(Example 22)
5.0 parts by weight of fish-derived water-soluble gelatin (water-soluble gelatin CSF, manufactured by Nippi) is dissolved in 1000 parts by weight of purified water (Japanese Pharmacopoeia purified water, Kennaga Pharmaceutical Co., Ltd.) at 40 ° C. and released at room temperature. After cooling, it was frozen with liquid nitrogen, and freeze-dried for one day and night with a freeze dryer (DC400, manufactured by Yamato Scientific Co., Ltd.). After sufficiently stirring 2.0 parts by weight of fish-derived water-soluble gelatin (FD product) that has been freeze-dried, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) is added and stirred at a temperature of 60 ° C. While dissolving. After dissolution, 0.6 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech Co., Ltd.) and allowed to cool at room temperature to obtain an edible composition.

(Example 23)
Purified water (Japanese Pharmacopoeia purified water, manufactured by Kennaga Pharmaceutical Co., Ltd.) 1000 parts by weight, pork-derived low molecular gelatin (pig bone gelatin AEP, manufactured by Nippi Co., Ltd.) 5.0 parts by weight at 60 ° C. and dissolved at room temperature. After cooling, it was frozen with liquid nitrogen, and freeze-dried for one day and night with a freeze dryer (DC400, manufactured by Yamato Scientific Co., Ltd.). After sufficiently stirring 2.0 parts by weight of pork-derived low molecular weight gelatin (FD product) that has been freeze-dried, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) is added and stirred at a temperature of 60 ° C. While dissolving. After dissolution, 0.6 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech Co., Ltd.) and allowed to cool at room temperature to obtain an edible composition.

(Examples 24-26)
According to the composition shown in Table 4, an edible composition was prepared in the same procedure as in Example 23. In place of pig-derived low molecular gelatin, pig-derived acid-treated gelatin (FD product) (AP-200F, manufactured by Nippi) in Example 24, pig-derived alkali-treated gelatin (FD product) (BP-200F, In Example 26, cattle-derived alkali-treated gelatin (FD product) (AD4, manufactured by Nippi) was used.

(Example 27)
5.0 parts by weight of κ-carrageenan (GENUGEL JPE-126, CP Kelco) is dissolved in 1000 parts by weight of purified water (Japan Pharmacopoeia purified water, Kennaga Pharmaceutical Co., Ltd.) at 70 ° C. and allowed to cool at room temperature. After that, it was frozen with liquid nitrogen, and freeze-dried for one day and night with a freeze dryer (DC400, manufactured by Yamato Kagaku Co., Ltd.). After sufficiently stirring 0.2 parts by weight of κ-carrageenan (FD product) that has been freeze-dried, 5.8 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) is added and stirring at a temperature of 85 ° C. Dissolved. After dissolution, 0.6 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech Co., Ltd.) and allowed to cool at room temperature to obtain an edible composition.

(Examples 28 and 29)
According to the composition shown in Table 4, an edible composition was prepared in the same procedure as in Example 27. Instead of κ-carrageenan, native type gellan gum (FD product) (Kelcogel LT100, CP Kelco) was used in Example 28, and tamarind gum (FD product) (Glyloid 3S, DSP Gokyo Food & Chemical Co., Ltd.) was used in Example 29. ) Was used.

(Comparative Example 11)
After 1000 parts by weight of purified water (Japanese Pharmacopoeia purified water, Kennaga Pharmaceutical Co., Ltd.) and 5.0 parts by weight of deacylated gellan gum (Kelcogel, CP Kelco) are dissolved by heating at 70 ° C. and allowed to cool at room temperature The sample was frozen with liquid nitrogen and freeze-dried for one day and night with a freeze dryer (DC400, manufactured by Yamato Kagaku Co., Ltd.). After sufficiently stirring 0.2 parts by weight of deacylated gellan gum (FD product) that has been freeze-dried, 5.8 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) is added and stirred at a temperature of 85 ° C. The solution was dissolved. After dissolution, 0.6 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech Co., Ltd.) and allowed to cool at room temperature to obtain an edible composition.

(Comparative Example 12)
According to the composition shown in Table 4, an edible composition was prepared in the same procedure as in Comparative Example 11. LM pectin (FD product) (GENU PECTIN Type LM-102AS-J, CP Kelco) was used in place of the deacylated gellan gum.

(Example 30)
9 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 60 ° C., 1.9 parts by weight of porcine-derived low molecular gelatin (pig bone gelatin AEP, manufactured by Nippi) and sodium carboxymethylcellulose (Serogen PR-S, manufactured by Daiichi Kogyo Seiyaku Co., Ltd.) 0.1 parts by weight was added and sufficiently stirred and dissolved. Then, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added, and Mix with stirring at temperature. After mixing, 1.5 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 31-36)
According to the composition shown in Table 5, an edible composition was prepared in the same procedure as in Example 30. Instead of carboxymethylcellulose, in Example 31, κ-carrageenan (GENUGELJPE126, manufactured by CP Kelco), in Example 32, ι-carrageenan (GENUVISO PJ-JPE, manufactured by CP Kelco), and in Example 33, LM pectin (GENU ectin). LM-102AS-J, CP Kelco), deacylated gellan gum (Kelcogel, CP Kelco) in Example 34, sodium alginate (Kimika Algin IL-2, Kimika) in Example 35, and Example 36. Psyllium seed gum (PG200, manufactured by MRC Polysaccharide) was used.

(Example 37)
8.8 parts by weight of purified water (Japanese Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) was heated to 70 ° C., 0.1 part by weight of κ-carrageenan (GENUGELJPE126, CP Kelco) and xanthan gum (Labor gum GS- C, DSP Gokyo Food & Chemical Co., Ltd.) 0.1 parts by weight, after sufficiently stirring and dissolving, glycerin (Wako Pure Chemical Industries, Ltd.) 4.0 parts by weight was added, and the temperature was 70 ° C. Mix with stirring. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 38 to 42)
According to the composition shown in Table 6, an edible composition was prepared in the same procedure as in Example 37. Instead of xanthan gum, iota-carrageenan (GENUVISCO PJ-JPE, CP Kelco) was used in Example 38, native gellan gum (Kelcogel LT100, CP Kelco) was used in Example 39, and psyllium seed gum (PG200) was used in Example 40. In Example 41, tragacanth powder (Tragant powder, manufactured by Bell Powder Chemical Co., Ltd.) was used. In Example 42, sodium alginate (Kimika Argin IL-2, manufactured by Kimika Corporation) was used.

(Example 43)
8.8 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 70 ° C., 0.1 part by weight of ι-carrageenan (GENUVISCO PJ-JPE, CP Kelco) and carboxymethylcellulose After adding 0.1 part by weight of sodium (Serogen PR-S, manufactured by Daiichi Kogyo Seiyaku Co., Ltd.) and sufficiently stirring and dissolving, 4.0 part by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) is added, and 70 ° C. The mixture was stirred at a temperature of. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 44 to 50)
According to the composition shown in Table 7, an edible composition was prepared in the same procedure as in Example 43. In place of sodium carboxymethylcellulose, sodium alginate (Kimika Argin IL-2, manufactured by Kimika) was used in Example 44, xanthan gum (Labor Gum GS-C, manufactured by DSP Gokyo Food & Chemical Co., Ltd.), and λ in Example 46. Carrageenan (GENEVISCO CSM-2, CP Kelco), deacylated gellan gum (Kelcogel, CP Kelco) in Example 47, native gellan gum (Kelcogel LT100, CP Kelco) in Example 48, Example In No. 49, psyllium seed gum (PG200, manufactured by MRC Polysaccharide) was used, and in Example 50, Tragant powder (Tragant powder, manufactured by Bell Powder Chemical Co., Ltd.) was used.

(Example 51)
8.8 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 70 ° C., tamarind gum (Glyloid 3S, DSP Gokyo Food & Chemical Co., Ltd.) 0.1 parts by weight and carboxy After adding 0.1 parts by weight of sodium methylcellulose (Serogen PR-S, manufactured by Daiichi Kogyo Seiyaku Co., Ltd.) and sufficiently stirring and dissolving, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added, The mixture was mixed with stirring at a temperature of ° C. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 52 to 62)
According to the composition shown in Table 8, an edible composition was prepared in the same procedure as in Example 51. In place of sodium carboxymethylcellulose, in Example 52, carboxyvinyl polymer (Carbopol 971PNF), in Example 53, LM pectin (GENU pectin LM-102AS-J, manufactured by Sanki), in Example 54, HM pectin (GENU pectin) USP-H, manufactured by Sanki Co., Ltd.), Example 55, sodium alginate (Kimika Argin IL-2, manufactured by Kimika), Example 56, xanthan gum (Labor gum GS-C, manufactured by DSP Gokyo Food & Chemical Co., Ltd.), Examples In 57, ι-carrageenan (GENUVISCO PJ-JPE, manufactured by CP Kelco), in Example 58, λ-carrageenan (GENEVISCO CSM-2, manufactured by CP Kelco), and in Example 59, deacylated gellan gum (Kelcogel, CP Kelc). o) native gellan gum (Kelcogel LT100, CP Kelco) in Example 60, psyllium seed gum (PG200, manufactured by MRC Polysaccharide) in Example 61, and tragacanth powder (tragant powder, bell) in Example 62 Powder Chemical Co., Ltd.) was used.

(Example 63)
8.8 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 80 ° C., and xanthan gum (Labor Gum GS-C, DSP Gokyo Food & Chemical Co., Ltd.) 0.1 parts by weight After adding 0.1 parts by weight of deacylated gellan gum (Kelcogel, CP Kelco) and sufficiently stirring and dissolving, 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added, and the temperature was 80 ° C. And mixed with stirring. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Example 64)
According to the composition shown in Table 9, psyllium seed gum (PG200, manufactured by MRC Polysaccharide) was used in Example 64 instead of deacylated gellan gum.

(Example 65)
8.8 parts by weight of purified water (Japanese Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 80 ° C., 0.1 part by weight of deacylated gellan gum (Kelcogel, manufactured by CP Kelco) and carboxyvinyl polymer ( (Carbopol 971PNF) 0.1 part by weight was added and sufficiently stirred and dissolved, and then 4.0 parts by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added and mixed at 80 ° C. with stirring. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 66 to 72)
According to the composition shown in Table 10, the edible composition was prepared in the same procedure as in Example 65. Instead of the carboxyvinyl polymer, LM pectin (GENU pectin LM-102AS-J, manufactured by Sanki Co., Ltd.) was used in Example 66, and HM pectin (GENU pectin USP-H, manufactured by Sanki Co., Ltd.) was used in Example 67. In Example 69, λ-carrageenan (GENEVISCO CSM-2, CP Kelco) in Example 69, native gellan gum (Kelcogel LT100, CP Kelco) in Example 70, In Example 71, psyllium seed gum (PG200, manufactured by MRC Polysaccharide) was used, and in Example 72, Tragant powder (Tragant powder, manufactured by Bell Powder Chemical Co., Ltd.) was used.

(Example 73)
8.8 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 70 ° C., and LM pectin (GENU pectin LM-102AS-J, manufactured by Sanki Co., Ltd.) 0.1 parts by weight and After adding 0.1 part by weight of native gellan gum (Kelcogel LT100, CP Kelco) and sufficiently stirring and dissolving, 4.0 part by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) was added, and the temperature was 70 ° C. And mixed with stirring. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 74 and 75)
According to the composition shown in Table 11, the edible composition was prepared in the same procedure as in Example 73. Instead of native gellan gum, psyllium seed gum (PG200, manufactured by MRC Polysaccharides) was used in Example 74, and tragant powder (Tragant powder, manufactured by Suzu Powder Chemical Co., Ltd.) was used in Example 75.

(Example 76)
8.8 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 70 ° C., HM pectin (GENU ectin LM-102AS-J, manufactured by Sanki Co., Ltd.), 0.1 parts by weight, and After adding 0.1 part by weight of carboxyvinyl polymer (Carbopol 971PNF) and sufficiently stirring and dissolving, 4.0 part by weight of glycerin (manufactured by Wako Pure Chemical Industries, Ltd.) is added and stirring at a temperature of 70 ° C. Mixed. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Example 77)
According to the composition shown in Table 12, an edible composition was prepared in the same procedure as in Example 76. In Example 77, psyllium seed gum (PG200, manufactured by MRC Polysaccharide) was used instead of the carboxyvinyl polymer.

(Example 78)
8.8 parts by weight of purified water (Japan Pharmacopoeia purified water, manufactured by Kenei Pharmaceutical Co., Ltd.) is heated to 70 ° C., 0.1 type by weight of native gellan gum (Kelcogel LT100, CP Kelco) and sodium carboxymethylcellulose ( Selogen PR-S (Daiichi Kogyo Seiyaku Co., Ltd.) 0.1 parts by weight was added and sufficiently stirred and dissolved. Then, glycerin (Wako Pure Chemical Industries, Ltd.) 4.0 parts by weight was added, and the temperature was 70 ° C. And mixed with stirring. After mixing, 1.9 g each was dispensed into a plastic blister case (Cryomold Standard (circular), Sakura Finetech) and dried in a vacuum dryer (DP63, Yamato Scientific) for 3 hours at 40 ° C. The edible composition was obtained by evaporating and further evaporating residual water in a desiccator with molecular sieves.

(Examples 79 to 83)
According to the composition shown in Table 13, an edible composition was prepared in the same procedure as in Example 78. In place of sodium carboxymethylcellulose, in Example 79, carboxyvinyl polymer (Carbopol 971PNF), in Example 80, sodium alginate (Kimika Argin IL-2, manufactured by Kimika), in Example 81, λ-carrageenan (GENEVISCO CSM-2, CP Kelco), Example 82 used psyllium seed gum (PG200, manufactured by MRC Polysaccharides), and Example 83 used Tragant powder (Tragant powder, manufactured by Bell Powder Chemical Co., Ltd.).

[Test method]
It was examined whether or not to reconstitute the jelly-like composition or jelly-form preparation by adding post-purification water, 50% glycerin-containing aqueous solution and drug-containing solution to each sample of Examples and Comparative Examples.
Whether or not the jelly was restored was evaluated as a jelly restoration property, and the time taken until the jelly was restored was evaluated as a jelly restoration time. Each evaluation standard is shown below. The results are shown in Tables 14-21.
In addition, as a drug containing solution, a cedar pollen extract solution (therapeutic standardized allergen extract cedar pollen 2000 JAU / mL, manufactured by Torii Pharmaceutical Co., Ltd.), a house dust extract solution (a therapeutic allergen extract subcutaneous injection “Torii” house dust 1: 10, Torii Pharmaceutical Co., Ltd.), and a porcine herb pollen extract solution (therapeutic allergen extract subcutaneous injection "Torii" pork herb pollen 1: 100, manufactured by Torii Pharmaceutical Co., Ltd.).

(1) Jelly recoverability (Evaluation 1, Evaluation 2, Evaluation 3)
In evaluation 1, when purified water was added, in evaluation 2, a 50% by weight glycerin aqueous solution was added, and in evaluation 3, evaluation was made regarding jelly restoration properties when a drug-containing solution was added.
The evaluation criteria are as follows.
3: Gelled completely and became uniform jelly.
2: Gelled and became jelly, but slightly non-uniform.
1: Gelled, but very soft and easy to collapse.
0: It did not gel but became a highly viscous sol.

(2) Jelly restoration time (Evaluation 1, Evaluation 2, Evaluation 3)
In evaluation 1, when purified water was added, in evaluation 2, a 50% by weight glycerin aqueous solution was added, and in evaluation 3, evaluation was made regarding the jelly restoration time when a drug-containing solution was added.
The evaluation criteria are as follows.
6: Formable jelly was obtained in less than 3 hours.
5: Formable jelly was formed in 3 hours or more and less than 6 hours.
4: A jelly with moldability was formed in 6 hours or more and less than 12 hours.
3: Formable jelly was formed in 12 hours or more and less than 24 hours.
2: A jelly with moldability was obtained in 24 hours or more and less than 48 hours.
1: A moldable jelly was formed in 48 hours or more and less than 168 hours.
In addition, regarding the sample of (1) jelly recoverability “0: no gelation and high viscosity sol”, the test was not performed and scored as 0.

When Examples 1 to 29 and Comparative Examples 1 to 12 shown in Tables 14 to 16 were compared, it was found that the purified water was clearly superior in absorbability and rapidly formed into a jelly. Although Examples 1-29 were excellent also regarding the absorbability of 50% glycerol aqueous solution, it was shown that considerable time is required for jelly reconstruction. In the system in which purified water and 50% glycerin aqueous solution shown in Table 17 were added to 0.1 mL to 10 mL, the jelly was completely only when 0.1 mL to 3 mL of purified water was added and 0.1 mL of 50% glycerin aqueous solution was added. It was shown that In addition, as shown in Table 18, the house dust extract extract solution, which is a drug-containing solution that does not contain glycerin, showed good results, but the cedar pollen extract extract solution and pig that are drug-containing solutions that contain glycerin. In the grass pollen extract solution, it was shown that considerable time was required for jelly restoration.

As shown in Tables 19 to 20, the edible compositions of Examples 30 to 83 had good results in all evaluation items. As shown in Table 21, the edible compositions of Examples 52 and 57 showed sufficiently good results even in the cedar pollen extract extract solution and the pork grass pollen extract extract solution, which are actually drug-containing solutions containing glycerin. there were.

The edible composition of the present invention can be suitably gelled to obtain a jelly-form preparation by post-adding the drug-containing solution, and the jelly-form preparation after addition of the drug-containing solution dissolves in the oral cavity. It can be. Moreover, since the edible composition of this invention does not contain water suitably and contains a non-volatile organic solvent, it is not necessary to consider the sterilization in a manufacturing process, and is suitable as a dosage form of a heat-sensitive drug.
More specifically, the edible composition of the present invention is preferably a water-free jelly-like composition, and comprises gelatin, κ-carrageenan, tamarind gum, and HM pectin as gelling agents. By using at least one selected from the group, it has a characteristic of gelling at room temperature and easily dissolved in saliva in the oral cavity.
Moreover, the edible composition of this invention can also control the dissolution time easily by controlling content of a non-volatile organic solvent. From the viewpoint that the dissolution time can be controlled, as a pharmaceutical dosage form that is absorbed from the oral mucosa and sublingual mucosa that require residence time in the oral cavity, for example, sensitize allergen from the sublingual mucosa. Suitable for sublingual desensitization therapy.
In addition, from the viewpoint of not containing water, the edible composition of the present invention does not require the addition of a sterilization step or preservative necessary for general jelly, and has an advantage in terms of production cost, It is also suitable as a dietary supplement and pharmaceutical dosage form for patients who need water restriction.
The jelly-like preparation obtained by using the edible composition of the present invention is generally known to improve storage stability of proteins and peptides, such as gelatin, polysaccharides and polyols such as glycerin and propylene glycol. Since it is suitably used, it is expected that a protein or peptide can be particularly maintained stably.
Of course, the jelly-form preparation of the present invention may be swallowed as it is, or may be swallowed after rapidly dissolving in the oral cavity. Furthermore, it is possible to expect the absorption from the oral mucosa and the sublingual mucosa by controlling the dissolution time in the oral cavity. Since it can be completely dissolved at body temperature, from the viewpoint that there is no residue feeling and that it does not contain water, the jelly-form preparation of the present invention has a QOL for patients with limited water, patients with difficulty swallowing, and caregivers. It can be greatly improved.

Claims (16)

An edible composition comprising a gelling agent,
An edible composition characterized in that it is gelled by adding a drug-containing solution to form a jelly-form preparation. The edible composition according to claim 1 which does not contain water. The edible composition according to claim 1 or 2, further comprising a non-volatile organic solvent that is compatible with the gelling agent. The edible composition according to claim 3, wherein the nonvolatile organic solvent is a polyhydric alcohol having 2 to 4 OH groups in the molecule and having 4 or less carbon atoms. The edible composition according to claim 3 or 4, wherein the nonvolatile organic solvent comprises at least one selected from the group consisting of glycerin, glycerin derivatives, propylene glycol, and propylene glycol derivatives. The edible composition according to claim 1, 2, 3, 4 or 5, wherein the gelling agent comprises at least one selected from the group consisting of gelatin, κ-carrageenan, HM pectin, native gellan gum, and tamarind gum. object. Gelling agents include gelatin, κ-carrageenan, native gellan gum, tamarind gum, ι-carrageenan / sodium carboxymethylcellulose, ι-carrageenan / sodium alginate, ι-carrageenan / xanthan gum, ι-carrageenan / λ-carrageenan, ι-carrageenan / Deacylated gellan gum, ι-carrageenan / silium seed gum, ι-carrageenan / tragacanth powder, xanthan gum / deacylated gellan gum, xanthan gum / silium seed gum, deacylated gellan gum / carboxyvinyl polymer, deacylated gellan gum / LM pectin , Deacylated gellan gum / sodium alginate, Deacylated gellan gum / λ-carrageenan, Deacylated gellan gum / Psyllium seed gum, Deacylated Erangamu / tragacanth powder, comprising LM pectin / psyllium seed gum, and, at least one member selected from the group consisting of LM pectin / gum arabic powder, tragacanth powder,
The edible composition according to claim 1, 2, 3, 4 or 5, wherein the non-volatile organic solvent is glycerin and / or a glycerin derivative. The gelling agent includes at least one selected from the group consisting of gelatin, κ-carrageenan, tamarind gum, and HM pectin,
The edible composition according to claim 1, 2, 3, 4 or 5, wherein the non-volatile organic solvent is propylene glycol and / or a propylene glycol derivative. Nonvolatile organic solvent contains glycerin and / or propylene glycol, and as a solution absorption accelerator, sodium carboxymethylcellulose, LM pectin, sodium alginate, xanthan gum, ι-carrageenan, λ-carrageenan, deacylated gellan gum, psyllium seed gum And at least one selected from the group consisting of tragacanth powder. A jelly-form preparation obtained by adding a drug-containing solution to the edible composition according to claim 1, 2, 3, 4, 5, 6, 7, 8 or 9. The jelly-form preparation according to claim 10, wherein the drug-containing solution is an injection solution or an oral solution. The jelly-form preparation according to claim 10 or 11, wherein the solvent contained in the drug-containing solution is at least one selected from the group consisting of water, glycerin, and propylene glycol. The jelly-form preparation according to claim 10, 11 or 12, wherein the blending amount of the gelling agent is 0.1 to 40% by weight based on the total weight of the jelly-form preparation. The edible composition contains a nonvolatile organic solvent that is compatible with the gelling agent, and the amount of the nonvolatile organic solvent is 10 to 99% by weight based on the total weight of the jelly-form preparation, The jelly-form preparation according to 11, 12, or 13. A step of mixing water, a gelling agent, and a non-volatile organic solvent compatible with the gelling agent, heating and dissolving to obtain a non-volatile organic solvent-containing gelling agent solution;
A step of dispensing or stretching the non-volatile organic solvent-containing gelling agent solution;
A step of solidifying by cooling or cooling to obtain an edible composition; and
A method for producing a jelly-form preparation comprising a step of adding a drug-containing solution to the edible composition to obtain a jelly-form preparation. Mixing, heating and dissolving water and a gelling agent to obtain a gelling agent solution;
Lyophilizing the gelling agent solution to obtain a readily soluble gelling agent;
A step of mixing a non-volatile organic solvent that is compatible with the readily soluble gelling agent into the easily soluble gelling agent, heating and dissolving to obtain a non-volatile organic solvent-containing gelling agent solution;
A step of dispensing or stretching the non-volatile organic solvent-containing gelling agent solution;
A step of solidifying by cooling or cooling to obtain an edible composition; and
A method for producing a jelly-form preparation comprising a step of adding a drug-containing solution to the edible composition to obtain a jelly-form preparation.