KR20130062691A - Rapid solid dispersion oral compsition for using wheat bran - Google Patents

Abstract

PURPOSE: An oral formulation of rapid-acting solid dispersion containing a wheat bran extract is provided to enhance dissolution in a gastrointestinal tract, and to quickly treat allergy. CONSTITUTION: An oral formulation of rapid-acting solid dispersion containing a wheat bran extract contains a solid dispersant containing the wheat bran extract and a soluble polymer as a carrier. The solid dispersant contains 0.5-300 parts by weight of the soluble polymer based on the rice bran extract. A method for manufacturing the oral formulation comprises: a step of mixing the rice bran extract, the soluble polymer, and a pharmaceutically acceptable excipient without a carrier function; and a step of spray-drying the mixture and preparing a solid dispersant. A solvent is selected from the group consisting of dichloromethane, chloroform, ethanol, methanol, acetone, isopropanol, and propanol. [Reference numerals] (AA) Concentration in blood(ng/ml); (BB) Comparative formulation; (CC) Test formulation; (DD) Time(hours)

Description

Rapid solid dispersion oral formulation of wheat bran extract and preparation method thereof {Rapid solid dispersion oral compsition for using Wheat Bran}

The present invention relates to a composition for improving allergic diseases using wheat bran extract.

The present invention relates to a fast-acting solid dispersion oral preparation of wheat bran extract with improved dissolution rate and bioavailability and a method for preparing the same.

The wheat bran used in the present invention is a patent application for improving allergic diseases using an active substance which can be isolated from the extract of wheat bran in 2010, Republic of Korea, the present invention (Korean Patent Application No. 1 0-2010-0138902 ).

By the way, although wheat bran extract has an excellent effect on improving allergic diseases, dissolution rate in gastrointestinal tract is about 40-50%, solubility and dissolution rate in digestive fluid during absorption into the body when administered to living body. Low and low biomembrane permeability, there is a disadvantage in that the bioavailability is lowered because the absorption of the drug is delayed, but there is still no prior art for solubilizing the formulation containing the bran extract and specific formulation.

In addition, the improvement of allergic diseases requires long-term use of drugs, and good medication compliance is required for taking pediatric patients, but fast-acting agents that reduce the onset of side effects caused by the increase in the dose required to have an effect have been required.

In order to solve the above problems, the present inventors have conducted many studies to formulate fast-acting oral preparations by increasing the bioavailability by excellent dissolution rate and oral absorption rate of wheat bran extract having an excellent effect on the improvement of allergic diseases. As a result, by adding a pharmaceutically acceptable excipient that does not have a carrier function of wheat bran extract, water-soluble polymer and solid dispersion, dissolved together in a solvent and spray-dried to prepare a solid dispersion by excellent dissolution rate and oral absorption rate It was confirmed that the utilization rate can be increased, and by using this, the present invention was completed by preparing a fast-acting oral preparation of wheat bran extract showing rapid drug release.

Accordingly, an object of the present invention is to provide a quick-dissolving solid dispersion oral preparation which can elute wheat bran extract quickly and can increase bioavailability by having an excellent oral absorption rate.

It is another object of the present invention to provide a method for preparing a fast dissolving solid dispersion oral preparation of wheat bran extract.

In order to achieve the above object, the present invention provides a fast-acting oral formulation of wheat bran extract containing a solid dispersion prepared by containing a water-soluble polymer as a wheat bran extract and a carrier.

In addition, the present invention is added to the bran extract, a water-soluble polymer and a solid dispersion of the pharmaceutically acceptable excipients that do not have a carrier function to dissolve together in a solvent and spray-dried to prepare a solid dispersion, characterized in that the wheat bran Provided is a method for preparing a fast-acting oral preparation of an extract.

As described above, the present invention provides a fast-acting solid dispersion oral preparation of wheat bran extract with improved dissolution rate and bioavailability and a method for preparing the same, thereby increasing the solubility and dissolution rate in the gastrointestinal tract and enhancing the biomembrane permeability. It can be usefully absorbed in vivo and can significantly increase the bioavailability. In addition, by presenting a solubilization method and a specific formulation method of the formulation containing wheat bran extract, which is a poorly soluble drug to coexist with the sustained release formulation in the prevention or treatment of allergic diseases to treat the underlying gastrointestinal diseases.

1 is a dissolution rate according to time after stirring the fast-acting solid dispersion oral preparation (test preparation) of the present invention containing a 300 mg of wheat bran extract in the pH = 1.2 buffer solution of Experimental Example 8 and the formulation (comparative) according to the comparative example 2 is a fast-acting solid dispersion oral preparation (test preparation) of the present invention containing 300 mg of bran extract in a pH = 6.8 buffer solution of Experimental Example 8 and a preparation (comparative) according to Comparative Example Compare the dissolution rate with time after
3 is a comparison of blood concentrations with time after oral administration of a fast-acting solid dispersion oral preparation of the present invention (test preparation) and a preparation according to a comparative example (comparison preparation) containing 10 mg of pinelic acid of Experimental Example 8 to mice. It is.

In the present invention, the bran extract is added with one or more water-soluble polymers and excipients that do not have a carrier function of a solid dispersion, dissolved together in one or more solvents, and then spray-dried to prepare a solid dispersion. A fast-acting oral preparation of the extract is formulated.

The bran extract may be used bran extract obtained by a conventional extraction method, in addition to

1) extracting wheat bran with alcohol or aqueous alcohol solution (step 1)

2) adding an alkaline solution to the extract obtained in step 1 and reacting at 80 ° C. for at least 12 hours (step 2)

3) neutralizing by adding an acidic solution to the extract obtained in step 2 (step 3), or

4) The extract obtained in step 3 may be obtained through a method for preparing wheat bran extract, which comprises a step (step 4) of lyophilization after concentration under reduced pressure.

The extraction method of the wheat bran extract is known to have an excellent effect on the allergy treatment, the effective dose is 300mg once, 900mg per day.

The water-soluble polymers used in the present invention exhibit hydrophilicity, and when they are spray-dried together with the wheat bran extract, they increase the solubility by hydrophilizing the environment around the wheat bran extract, and also serve to minimize the activation energy required to dissolve the drug. It also plays a role in maximizing the solubility and dissolution rate of the wheat bran extract and enhancing the membrane permeability while maintaining physical and chemical stability.

Preferred examples of the water-soluble polymer are methyl cellulose, ethyl cellulose, hydroxy methyl cellulose, hydroxy ethyl cellulose, hydroxy methyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, and carboxymethyl cellulose.

Cellulose derivatives comprising sodium and these carboxymethyl celluloses, polyvinyl alcohol, polyvinylpyrrolidone or copolymers comprising the same, polyvinylacetate, polyalkene oxide or polyalkeneglycol, polyethylene-polypropylene polymers

Etc., one or two or more kinds of the above polymers may be used in combination.

The water-soluble polymer is preferably contained 0.5 ~ 300 parts by weight relative to the bran extract.

In addition, the solid dispersion prepared according to the present invention may disperse a pharmaceutically acceptable excipient in a solution at this time to perform a desired process, the excipient used herein is simply irrelevant to the carrier of the solid dispersion It is intended to facilitate the granulation operation. Excipients added to the present invention include surfactants, additives such as fatty acids or fatty alcohols, sugars such as white sugar, macion syrup, white sugar, gelatin, sugar and starch syrup, glidants such as magnesium stearate, talc, colloidal silicon dioxide, Excipients such as microcrystalline cellulose, calcium dihydrogen phosphate, starch, mannitol, polyvinylpyrrolidone, sodium starch glycolate, crospovidone, low-substituted hydroxypropylcellulose, calcium disintegrating agents such as calcium carboxymethylcellulose, It may further include antioxidants, flavoring agents, preservatives, fragrances, sweeteners, pigments, pH adjusting agents and viscosity adjusting agents to prevent oxidation, these are preferably added in the usual amount of use commonly used for wheat bran extract. .

The surfactant added to the present invention may use various surfactants including pharmaceutically acceptable anionic, cationic, nonionic or amphoteric surfactants. Specifically, polyoxyethylene sorbitan fatty acid ester, sorbitan fatty acid ester, polyoxyethylene fatty acid ester, polyoxyethylene polyoxypropylene block copolymer (polyoxyethylene polyoxypropylene block copolymer), polyoxyethylene polyoxypropylene copolymer, reactant of natural or hydrogenated vegetable oil and ethylene glycol, sodium dioctylsulfosuccinate (dioctylsulfosuccinic acid sodium salt), lauryl sulfonic acid sodium salt, phospholipids, propylene glycol mono or di fatty acid esters, natural vegetable oils of triglycerides and polyalkylene polyols Trans-ester Reaction products, mono-, di- or mono / di glycerides, mixtures of propylene glycol mono or di fatty acid esters with mono-, di- or mono / di glycerides, and One or more selected from the group consisting of the derivatives can be used.

Preferably the surfactant is a polyoxyethylene polyoxypropylene block copolymer, a reaction product of natural or hydrogenated vegetable oils with ethylene glycol, polyoxyethylene sorbitan fatty acid esters and propylene glycol mono or di fatty acid esters with mono-, di- Or a mixture of mono / diglycerides.

Fatty acids or fatty alcohols that may be used in the composition of the present invention include citric acid, oleic acid, stearyl alcohol, stearyl alcohol, myristic acid, linoleic acid or lauric acid. (lauric acid), capric acid (capric acid), caprylic acid (caprylic acid), caproic acid (caproic acid) and the like can be used, but is not limited thereto.

Antioxidants that can be used in the compositions of the present invention are butylated hydroxytoluene, sodium bisulfite, α-tocopherol, vitamin C (ascorbic acid), β-carotene ( β-carotin, tocopherol acetate, fumaric acid, nalic acid, butylated hydroxyanisole, propyl galate and sodium ascorbate ascorbate) may be used, but is not limited thereto.

Flavoring agents that can be used in the composition of the present invention may be mixed fruit flavor, apple flavor, strawberry flavor, cherry flavor, peppermint flavor, vanilla flavor, yogurt flavor, drink flavor and the like, but are not limited thereto.

Preservatives that can be used in the composition of the present invention may be used, but are not limited to benzoic acid, sodium benzoate, ethyl paraben, methyl paraben, propyl paraben and the like.

Perfume that can be used in the composition of the present invention may be used, but is not limited to peppermint brain, peppermint oil, orange oil, clove oil, cinnamon oil, strawberry essence and other common fruit flavor and plant essence.

Sweeteners that can be used in the compositions of the present invention may be used, but are not limited to white sugar, glucose, fructose, aspartame, stevioside, sorbitol, mannitol, oligosaccharides, syrup, macion syrup, and the like.

The pigments that can be used in the compositions of the present invention are green No. 3, red No. 2, red No. 3, blue No. 1, blue No. 2, yellow No. 4, yellow No. 5, water-soluble mannitol, caramel, titanium oxide, ferric oxide, etc. Can be used, but is not limited to these.

PH adjusting agents that can be used in the compositions of the present invention are sodium carbonate, sodium hydroxide, potassium hydroxide, triethanolamine, monoethanol

Min may be used, but is not limited to these.

Viscosity modifiers that may be used in the compositions of the present invention, acacia, bentonite, alginic acid, propylene glycol alginate, polyvinylpyrrolidone, polyvinyl alcohol ), Carbopol, polycarbopil, tragacanth gum, xanthangum and the like may be used, but are not limited thereto.

The other pharmaceutically acceptable additives are preferably included in 100 parts by weight or less based on wheat bran extract.

On the other hand, the present invention provides a method for preparing a fast-acting oral preparation of wheat bran extract, characterized in that to prepare a solid dispersion by dissolving the wheat bran extract and a water-soluble polymer together in a suitable solvent. In this case, for the purpose of improving the fluidity of the spray dried product, an appropriate excipient may be added and dispersed, followed by spray drying. In particular, in the present invention, by adopting the spray drying as a single process, it is possible to improve the economics and productivity according to the production of wheat bran extract-containing solid dispersion.

When spray drying, the viscosity and solid content of the spray drying liquid, the appearance and flowability of the spray drying product, the particle size of the spray drying product, the particle size distribution, etc. should be taken into consideration. This greatly influences the physical properties of the spray dried material. The injection temperature should be set within a range that does not cause any physical or chemical changes to the bran extract and the polymer used, and the injection speed and injection pressure of the spray liquid should be carried out in consideration of the drying capacity of the spray dryer. In particular, the exhaust temperature is most closely related to the optimization of the whole process and needs to be carefully controlled. The higher the spray pressure, the lower the solids content of the spray drying solution, the smaller the particle size of the spray dried product. The higher the intake and exhaust temperatures, the higher the fluidity of the particles, but the higher the bulk density.

When the final spray dried product is formulated into tablets or capsules, it is important not only to have physical properties that can satisfy the pharmaceutical properties such as disintegration and dissolution of the formulation itself, but also to ensure that these properties are not lost during the formulation process. Accordingly, the present invention provides a method of optimizing spray drying conditions and other conditions to increase the solubility of wheat bran extract and at the same time have a pharmaceutically acceptable characteristic.

The preparation method according to the preferred spray drying conditions are specifically

1) dissolving wheat extract and water soluble polymer and optionally other pharmaceutically acceptable additives in a solvent (step 1); And

2) the spray drying solution of step 1

Spray drying liquid injection amount: 30-700 ml / min,

Spray drying pressure: 0.5-7 kg / cm 2,

Spray drying intake temperature: 80-250 degreeC,

Spray drying exhaust temperature: 40-150 degreeC,

Solid content of spray drying liquid: 0.5 to 30.0%

Spray drying is carried out under the conditions of (step 2).

At this time, the solvent for dissolving the drug and the water-soluble polymer in the present invention is a pharmaceutically acceptable solvent that can dissolve both at the same time

May be used, and examples thereof include dichloromethane, chloroform, ethanol, methanol, acetone, isoprotanol, propanol, and the like, or a mixture of two or more thereof, but is not limited to the solvents exemplified above. .

In addition, the present invention provides a formulation in which the bran extract-containing solid dispersion is formulated into tablets, pills, tablets, hard capsules, soft capsules, suspensions, suspension syrups, dry syrups, etc. by conventional pharmaceutical methods. do.

Hereinafter, the present invention will be described in detail by examples. However, the following examples are only for illustrating the present invention, and the scope of the present invention is not limited by the examples.

Example 1 Preparation of Solid Dispersion Containing Bran Extract 1

According to the method described in Korean Patent Application No. 2003-41628, 100 grams of wheat bran extract and 100 hydroxypropylmethylcellulose extracted from harmful components were dissolved in 1750 grams of 1: 1 (mass ratio) mixed solvent of dichloromethane and ethanol. 10 grams of talc was added and well dispersed to prepare a spray dried liquid. The spray dried liquid was spray-dried under the following conditions using a spray dryer (Mobile Minor ™) to prepare a solid extract containing bran extract.

Spray drying liquid injection amount: 50-60 ml / min,

Spray drying pressure: 3 kg / cm 2,

Spray drying intake temperature: 105-115 degreeC,

Spray drying exhaust temperature: 55-65 degrees Celsius,

Example 2 Preparation of Solid Extract Containing Bran Extract 2

In the same manner as in Example 1, except that 100 grams of polyvinylpyrrolidone was used as the water-soluble polymer.

It was carried out to prepare a bran extract-containing solid dispersion.

Example 3 Preparation of Solid Dispersion Containing Bran Extract 3

The same method as in Example 1, except that 100 grams of methyl cellulose was used as the water-soluble polymer,

To prepare a bran extract-containing solid dispersion.

Example 4 Preparation of Solid Dispersion Containing Bran Extract 4

Except for using 100 grams of polyvinyl alcohol as a water-soluble polymer in the same manner as in Example 1, under the same conditions

It was carried out to prepare a bran extract-containing solid dispersion.

Example 5 Preparation of Wheat Flour Extract-Containing Solid Dispersion 5

The same method as in Example 1, except that 100 grams of sodium carboxymethylcellulose was used as the water-soluble polymer.

Under the same conditions, a wheat bran extract-containing solid dispersion was prepared.

Example 6 Preparation of Solid Dispersion Containing Bran Extract 6

100 grams of hydroxypropylmethylcellulose and 50 grams of polyoxyethylene polyoxypropylene block copolymer as water-soluble polymer

Was dissolved in a solvent, 10 grams of precipitated calcium carbonate was added to disperse well, and the bran extract-containing solid dispersion was prepared by the method of Example 1.

Example 7 Preparation of Solid Dispersion Containing Bran Extract 7

A wheat bran extract-containing solid dispersion was prepared in the same manner as in Example 1, except that 100 grams of hydroxypropyl cellulose and 30 grams of a reaction product of natural or hydrogenated vegetable oil and ethylene glycol were used as a polymer. It was.

Example 8 Formulation of Solid Dispersion 1

After homogeneously mixing 34.0 grams of the solid dispersion composition prepared in Example 1 with 39.1 grams of microcrystalline cellulose and 26.0 grams of calcium carboxymethyl cellulose, granules were prepared using a roller compactor by dry granulation. After mixing 1.0 gram of gross magnesium stearate and filling it in an automatic capsule filling machine, a capsule was prepared.

Example 9 Formulation of Solid Dispersion 2

38.6 grams of the solid dispersion composition prepared in Example 6 were mixed homogeneously with 29.0 grams of microcrystalline cellulose and 21.7 grams of calcium carboxymethyl cellulose, and then granulated using a roller compactor by dry granulation. After mixing 0.8 grams of magnesium stearate as a lubricant, the capsules were prepared by filling in an automatic capsule filling machine.

Example 10 Formulation of Solid Dispersion 3

30.5 grams of the solid dispersion composition prepared in Example 7 was homogeneously mixed with 29.0 grams of microcrystalline cellulose, 25.8 grams of lactose, and 5.0 grams of calcium carboxymethylcellulose, and then granulated using a roller compactor by dry granulation. After manufacturing

Tablets were prepared by mixing 4.5 grams of crospovidone as a disintegrant and 0.8 grams of magnesium stearate as a lubricant.

Example 11 Formulation of Solid Dispersion 4

20.5 grams of the solid dispersion composition prepared in Example 7 was homogeneously mixed with 50.0 grams of lactose and 5.0 grams of calcium carboxymethyl cellulose, and then granulated by using a roller compactor by dry granulation. Roger substituted hydroxypropyl cellulose

Tablets were prepared by mixing 5.0 grams and 0.5 grams of lubricant magnesium stearate.

<Comparative Example>

8 kg of lactose and 4 kg of corn starch were mixed in a high speed mixer. This mixture was mixed with 3 Kg of wheat bran extract prepared in the same manner as in Example 1, combined in a coalescer, and then assembled into No. 20 sieve. After hot-air drying at 60 degreeC, it granulated by the No. 20 sieve and obtained granules. The granules were prepared by filling the granules into an automatic capsule filling machine.

Experimental Example 1 Solubility Comparison Experiment

The solubility of oral test preparations comprising the pharmaceutical composition of the extract of wheat bran extract by the spray drying method of the present invention and oral comparative formulations comprising the pharmaceutical composition of the extract of wheat bran prepared by a conventional wet granulation method was measured and compared.

Specifically, the pH condition (pH = 1.2) and the small intestine in the gastrointestinal tract of the capsule test preparation including the composition of the wheat bran extract prepared from Example 8 and the pharmaceutical composition of the anchovy extract prepared from the comparative example The solubility of the drug was measured under pH conditions (pH = 6.8) in the large intestine.

The experimental method is as follows.

In an oral preparation prepared from Example 8 and Comparative Example, an amount corresponding to 300 mg of wheat bran extract was taken, and buffered solution of pH 1.2 and pH 6.8 (2.0 g of sodium pharmaceutical solution of the 8th K.P. To 1 L. A pH 6.8 solution of 0.2 mol / L potassium dihydrogen phosphate solution was added to 250 mL of 118 mL of 0.2 mol / L sodium hydroxide solution and water to make 1 L.) After the solution was stirred at 37 ° C. for 1 hour, the solubility was measured. Solubility was measured using HPLC after centrifugation.

The results are shown in Table 1.

Table 1.

Solubility and comparison at pH = 1.2 and pH = 6.8 (unit: µg / ml)

Formulation pH 1.2 pH 6.8

Comparative Preparation 1.5 3.4

Test product 8.1 8.7

Test / Comparison 540% 256%

As shown in Table 1, the solubility of the oral test preparation prepared in Example 8 of the present invention was 8.1 μg / ml and 8.7 μg / ml at pH = 1.2 and pH = 6.8, respectively, and prepared from the comparative example. The solubilities of the prepared oral comparative formulations were 1.5 μg / ml and 3.4 μg / ml, respectively.

All. In addition, it can be seen that the solubility of the oral preparation according to the present invention is 5.4 times and 2.6 times higher at pH = 1.2 and pH = 6.8 when the solubility is compared.

Therefore, the fast-acting oral preparation by the solid dispersion according to the present invention can be seen that the solubility is very high in the gastrointestinal small intestine and large intestine pH conditions, compared to the preparation prepared by the conventional method, it is constantly dissolved in various pH conditions It can be seen that.

Experimental Example 2 Dissolution Rate Comparison Experiment

The dissolution rate of the oral preparation comprising the composition of the fast-acting solid dispersion oral preparation of wheat bran extract of the present invention and the wheat bran extract prepared by a conventional wet granulation method was measured and compared.

The experimental method is as follows.

A buffer solution of pH = 1.2 and pH = 6.8 prepared in the same manner as Experimental Example 1 by taking an amount corresponding to 60 mg of wheat bran extract in an oral preparation comprising a composition of wheat bran extract prepared in Example 8 and Comparative Example 500 mL was added to the dissolution tester vessel and stirred at 100 rpm. The content of wheat bran extract was eluted by the paddle method and extracted therefrom.

The dissolution rate measured at pH = 1.2 is shown in FIG. 1, and the dissolution rate measured at pH = 6.8 is shown in FIG. 2.

As shown in Figure 1 and Figure 2, the oral preparation prepared in Example 8 of the present invention (test formulation) showed a dissolution rate of more than 70% for 10 minutes at pH 1.2 and pH 6.8, 20 minutes to 60 minutes Showed a constant dissolution rate.

On the other hand, the oral preparation prepared in Comparative Example (comparative) showed a lower dissolution rate for each stirring time compared to the oral preparation prepared in Example 8.

Thus, as shown in Figures 1 and 2 oral preparations according to the present invention has a higher dissolution rate at pH = 1.2 and pH = 6.8 compared to the oral preparations prepared from the comparative example, in particular a constant dissolution rate even at various pH Excellent dissolution properties

Have

Experimental Example 3 Blood Concentration Comparison Experiment

When the oral preparations according to the present invention and the oral preparations prepared from Comparative Examples were administered to rats, blood concentrations were measured and compared.

The experimental method is as follows.

250-300 g of experimental male white rats (Sprague-Dawely series) were used for the experiment after adapting for about 1 to 2 weeks. Mice fasted for at least 24 hours prior to the start of the experiment were anesthetized with ether and the canal of the left femoral artery was inserted to insert a tube to which a 50 IU / ml heparin-filled syringe was connected. After about 2 hours, when the rat awoke from anesthesia, the solid dispersion prepared in Example 8 and the preparation prepared in Comparative Example were administered with a dose of 20 mg / kg of pinellinic acid using an oral sonde.

0, 5, 10, 20, 30, 1, 2, 4, 6, 8 and 12 hours after administration of the formulation, blood was collected from the left femoral artery at 10,500 rpm. Centrifuged for minutes and plasma was separated and stored at -20 ° C until analysis.

The content of pinellinic acid in the blood was quantified using HPLC.

The results are shown in Fig.

As shown in FIG. 3, the blood concentration when the solid dispersion preparation (test preparation) of the present invention prepared from Example 8 was administered to a rat was measured by the blood concentration when the preparation (comparative preparation) prepared from the comparative example was administered. It can be seen that higher than the concentration. In addition, it can be seen that the solid dispersion agent according to the present invention has a maximum blood concentration of 2 times or more and a blood concentration area (AUC) of 10 times or more compared to the preparation prepared from the comparative example.

Through such experiments, it can be seen that the solid dispersion according to the present invention has a higher bioavailability than the preparation prepared from the comparative example.

Claims (6)

 Fast-acting oral formulation of wheat bran extract comprising a solid dispersion prepared by containing a bran extract and a water-soluble polymer as a carrier  The method of claim 1, wherein the water-soluble polymer is methyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose and these carboxymethyl Cellulose Derivatives Including Chill Cellulose, Polyvinyl Alcohol, Polyvinyl Pyrrolidone Or Copolymers Comprising The Same, Fast-acting oral preparation of bran extract, characterized in that at least one selected from the group consisting of  The fast-acting oral preparation of wheat bran extract according to claim 2, wherein the water-soluble polymer is contained in an amount of 0.5 to 300 parts by weight based on the wheat bran extract.  The extract of claim 1, wherein the oral preparation is selected from the group consisting of tablets, powders, granules, pills, hard capsules, soft capsules and oral solutions containing aqueous solutions. Oral preparations It is added to a solvent by adding a pharmaceutically acceptable excipient which does not have a carrier function of wheat bran extract, water-soluble polymer and solid dispersion.
Method for producing a fast-acting oral preparation of wheat bran extract, characterized in that to prepare a solid dispersion by dissolving after spraying The method of claim 5, wherein the solvent is at least one selected from the group consisting of dichloromethane, chloroform, ethanol, methanol, acetone, isopropanol and propanol.

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