JP2023126190A - Oral pharmaceutical composition - Google Patents

Abstract

To provide a liquid or semisolid oral pharmaceutical composition containing cinnamon bark or its extract and agar, wherein the oral pharmaceutical composition is less likely to form deposits when stored at high temperatures.SOLUTION: A liquid or semisolid oral pharmaceutical composition contains following components (A), (B) and (C): (A) cinnamon bark or its extract, (B) agar and (C) at least one selected from following components (C-1) and (C-2): (C-1) carrot or its extract and (C-2) a vitamin B group.SELECTED DRAWING: None

Description

The present invention relates to oral pharmaceutical compositions in liquid or semi-solid form.

Cinnamomum cassia Blume is the bark of Cinnamomum cassia Blume of the Lauraceae family or other plants of the same genus, with part of the bark or periderm removed. Keihi is known to have various pharmacological effects such as promoting stomach health, analgesia, sedation, sweating and fever reduction, and lowering blood pressure, and is widely used as a component of pharmaceuticals.

Incidentally, in recent years, fluid and viscous gel-like oral preparations are increasingly being adopted as pharmaceutical forms. The reason behind the adoption of gel-like oral preparations is that formulations that are easy to administer, ingest, and swallow are preferred, especially in relation to the increasing number of people with swallowing disorders due to the increasing number of elderly people in developed countries. This is thought to be due to the fact that consumers prefer a form that can be easily taken in a short period of time and can reduce the feeling of hunger.

Oral preparations containing jelly-formed Chinese herbal medicines include, for example, bitterness-reducing compositions in which a bitter substance such as Shosaikoto is made into a jelly-like form using alginate and its coagulant (Patent Document 1), and jelly preparations containing Chinese herbal medicines. A Chinese herbal jelly pharmaceutical composition (Patent Document 2) using at least one of carrageenan, carob bean gum, and xanthan gum as a base is known.

Japanese Patent Application Publication No. 4-235136 Japanese Patent Application Publication No. 2004-59503

On the other hand, the present inventor investigated the development of a liquid or semi-solid oral preparation containing cinnamon bark or its extract using agar, and found that precipitates formed in the preparation under high temperature storage. . After medicines are delivered to patients, they may be stored under particularly high temperature conditions. Therefore, it is important to develop technology to suppress the formation of precipitates during storage at such high temperatures. This will lead to the provision of medicines. However, the storage stability of liquid or semi-solid oral preparations containing cinnamon bark or its extract using agar has not been sufficiently studied so far.

Therefore, an object of the present invention is to provide a liquid or semi-solid oral pharmaceutical composition containing cinnamon bark or an extract thereof and agar, which suppresses the formation of precipitates during high-temperature storage. It is about providing.

Therefore, as a result of intensive studies to solve the above problems, the present inventors have surprisingly found that by containing carrot or an extract thereof and one or more selected from the B group of vitamins together with cinnamon bark or an extract thereof and agar. It has been found that the generation of precipitates during high-temperature storage can be suppressed, and the present invention has been completed.

That is, the present invention comprises the following components (A), (B) and (C):
(A) Cinnamon or its extract (B) Agar (C) One or more selected from the following ingredients (C-1) and (C-2) (C-1) Carrot or its extract (C-2) A liquid or semi-solid oral pharmaceutical composition containing vitamin B group is provided.

According to the present invention, it is possible to provide a liquid or semi-solid oral pharmaceutical composition containing cinnamon bark or an extract thereof and agar, which does not easily cause precipitation under high temperature storage and has good storage stability.

The oral pharmaceutical composition of the present invention is a pharmaceutical composition that is directly administered orally, and is in a liquid or semi-solid form at room temperature (25°C). This will be explained in detail below.

The oral pharmaceutical composition of the present invention contains cinnamon bark or an extract thereof as component (A).
In the present invention, "Keihi" (Cinnamon bark) is a herbal medicine whose base plant is Cinnamomum cassia Blume (Lauraceae), but it is a herbal medicine from which part of the bark or periderm of Cinnamomum cassia Blume (Lauraceae) has been removed. is preferred. The form of cinnamon can be adjusted as required, and the whole herbal medicine can be cut or crushed into small pieces, small chunks, or ground into powder. For example, "cinnamon bark powder" made from powdered cinnamon bark can be used in the present invention.
"Keihi nut extract" is something that has been subjected to some kind of extraction process. In addition to the extraction process, the "extract of cinnamon bark" includes those that have been subjected to processing treatments such as heating, drying, and pulverization. Specifically, after cutting the cinnamon bark to an appropriate size as necessary, the extract is extracted by adding an appropriate extraction solvent, or the infused solution is concentrated (soft extract, tincture, etc.), and then these are dried. Products (dried extract, etc.) are also included in the "extract of cinnamon bark" of the present invention.
In the present invention, cinnamon bark extract or extract thereof is preferably cinnamon bark extract.

The manufacturing method of cinnamon bark extract is not particularly limited, and for example, the method described in the 17th revised Japanese Pharmacopoeia, General Preparation Rules, "extracts," "infusions/decoctions," "tinctures," and "liquid extracts." It can be produced by referring to known methods for producing plant extracts. Specifically, it can be produced by cutting, heating, pulverizing, etc., as necessary, and then extracting by adding an appropriate extraction solvent. The obtained extract may be further concentrated, dried, etc., if necessary.

Examples of the extraction solvent include lower monohydric alcohols such as methanol, ethanol, isopropanol, and n-butanol (preferably linear or branched aliphatic alcohols having 1 to 6 carbon atoms); ethylene glycol, propylene; Lower polyhydric alcohols such as glycol, 1,3-butylene glycol, and glycerin; Ethers such as diethyl ether; Ketones such as acetone and ethyl methyl ketone; Esters such as ethyl acetate; Nitriles such as acetonitrile; Pentane, hexane Alkanes such as , cyclopentane and cyclohexane; Halogenoalkanes such as dichloromethane and chloroform; Aromatic hydrocarbons such as benzene and toluene; Amides such as dimethylformamide; Sulfoxides such as dimethyl sulfoxide; Water (including hot water) etc. Each of these may be used alone, or two or more types may be used in combination. In the present invention, the extraction solvent is preferably a solvent containing at least water or a linear or branched aliphatic alcohol having 1 to 6 carbon atoms; More preferably, the solvent is selected from aliphatic alcohols and mixtures of water/linear or branched aliphatic alcohols having 1 to 6 carbon atoms, and is selected from the group consisting of water, ethanol, and water/ethanol mixtures. It is particularly preferable that the solvent be used as a solvent.

The extraction operation is not particularly limited, and any known method used for extraction operations from plants can be adopted, such as immersion in an extraction solvent (chilling, hot immersion, percolation, etc.), supercritical fluid or Examples include extraction using critical fluid. In addition, in order to increase extraction efficiency, stirring or homogenization in an extraction solvent may be performed.
The extraction temperature is not particularly limited and varies depending on the extraction solvent used, extraction procedure, etc., but is preferably about 5° C. to below the boiling point of the extraction solvent.
The extraction time is not particularly limited and varies depending on the extraction solvent used, extraction procedure, etc., but is preferably about 1 hour to 14 days.

In the present invention, commercially available products can be used as cinnamon bark or extracts thereof. Specific commercial products include keihi tincture, keihi tinki-N, keihi extract, keihi liquid extract, keihi dried extract, and Japanese pharmaceutical cinnamon bark oil ( All of the above are manufactured by Nippon Powder Yakuhin Co., Ltd.), and the like.

The content of cinnamon bark or its extract in the oral pharmaceutical composition of the present invention is 0.001 to 3 mass based on the total mass of the oral pharmaceutical composition, from the viewpoint of taste and suppressing precipitation of cinnamon bark or its extract. %, more preferably 0.01 to 2% by mass, even more preferably 0.03 to 1% by mass, particularly preferably 0.05 to 0.2% by mass. .
In addition, when the content of cinnamon bark or its extract is converted into the amount of crude drug, it is preferably contained in an amount of 0.01 to 50% by mass in terms of the amount of crude drug, based on the total weight of the oral pharmaceutical composition. It is more preferable to contain 0.05 to 30% by weight, even more preferably to contain 0.1 to 10% by weight, and particularly preferably to contain 1 to 5% by weight.

The oral pharmaceutical composition of the present invention contains agar as component (B).
Agar is a type of galactan consisting of agarose, the main component of a viscous polysaccharide, and agaropectin, a subcomponent, contained in the cells of red algae. Agar can be obtained from the genus Amanita in the family Gelidium, such as Amanita vulgare, and the genus Amanita in the family Gracilaria.
In the present invention, commercially available agar such as powdered agar, filamentous agar, and rod-like agar can be used as the agar.

The content of agar in the oral pharmaceutical composition of the present invention is 0.001 to 5% by mass based on the total mass of the oral pharmaceutical composition, from the viewpoint of taste and suppressing precipitation of cinnamon bark or its extract. The content is preferably 0.005 to 3% by mass, more preferably 0.01 to 1% by mass, and particularly preferably 0.05 to 0.5% by mass.

The oral pharmaceutical composition of the present invention contains as component (C) one or more selected from (C-1) ginseng or an extract thereof, and (C-2) vitamin B group.
In the present invention, "ginseng" is a crude drug whose origin is Panax ginseng CA Meyer (Panax schinseng Nees) (Araliaceae Araliaceae); Preferably lightly blanched. The form of carrot can be adjusted as necessary. For example, "carrot powder", which is obtained by drying and powdering whole herbal medicine, can be used in the present invention.
“Carrot extract” is carrots that have been subjected to some kind of extraction treatment. Note that "carrot extract" also includes those that have been subjected to processing treatments such as heating, drying, and pulverization in addition to extraction treatment. Specifically, after cutting carrots to an appropriate size as necessary, the extract is extracted by adding an appropriate extraction solvent, or the extracted solution is concentrated (soft extract, tincture, etc.), and then these are dried. Carrot extracts (dried extracts, etc.) are also included in the "carrot extract" of the present invention.
In the present invention, carrot extract is preferred as the carrot or extract thereof.

The method for producing the carrot extract is not particularly limited, and it can be produced in the same manner as the above-mentioned "cinnamon extract".
In the present invention, commercial products can be used as carrots or extracts thereof. Specific commercial products include carrot powder, carrot extract (manufactured by Nippon Powder Yakuhin Co., Ltd.), Riken ginseng dried extract ( (manufactured by Riken Kagaku Kogyo), etc.

The content of ginseng or its extract in the oral pharmaceutical composition of the present invention is 0.01 to 10% by mass based on the total mass of the oral pharmaceutical composition, from the viewpoint of suppressing the precipitation of cinnamon bark or its extract. The content is preferably 0.05 to 5% by mass, more preferably 0.1 to 3% by mass, and particularly preferably 0.15 to 1% by mass.
In addition, when converting the content of ginseng or its extract into the amount of herbal medicine, it is preferably contained in an amount of 0.01 to 15% by mass in terms of the amount of herbal medicine based on the total weight of the oral pharmaceutical composition. The content is more preferably 1 to 10% by mass, even more preferably 0.5 to 5% by mass, and particularly preferably 1 to 3% by mass.

In addition, in the oral pharmaceutical composition of the present invention, the content ratio of cinnamon bark or an extract thereof to carrot or an extract thereof is 1 part by mass of cinnamon bark or an extract thereof, from the viewpoint of suppressing precipitation of cinnamon bark or an extract thereof. On the other hand, 0.1 to 50 parts by weight of carrot or an extract thereof is preferably 0.1 to 50 parts by weight, more preferably 1 to 30 parts by weight, and particularly preferably 3 to 10 parts by weight. In addition, when converting the content of cinnamon bark or its extract, and carrot or its extract into the amount of the crude drug, from the same point of view, carrots converted to the crude drug should be added to 1 part by mass of cinnamon bark converted to the crude drug. It is preferably 0.1 to 200 parts by weight, more preferably 1 to 100 parts by weight, and particularly preferably 10 to 50 parts by weight.

In the present invention, the "vitamin B group" includes vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, and vitamin B12, and these may be used alone or in combination of two or more. Can be used.
"Vitamin B1" includes thiamin itself, as well as its derivatives (bisthiamine, thiamine disulfide, dicethiamine, fursulthiamine, octothiamine, cycothiamine, cetothiamine, bisbuthiamine, bisbentiamine, fursulthiamine, prosulthiamine, benzene). Fothiamine, thiamine diphosphate, etc.) and their salts (inorganic acid salts such as nitrates, hydrochlorides, sulfates, etc.) are also included, and in the present invention, these are used alone or in combination of two or more types. be able to.
"Vitamin B2" includes not only riboflavin itself, but also its derivatives (flavin adenine dinucleotide, riboflavin butyrate, riboflavin phosphate, etc.) and their salts (alkali metal salts such as sodium salt, etc.), and the present invention These can be used alone or in combination of two or more.
"Vitamin B3" includes nicotinic acid and nicotinamide itself, as well as their derivatives (inositol hexanicotinate, nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide phosphate, hepronicate, etc.) and their salts. In the present invention, these can be used alone or in combination of two or more.
"Vitamin B5" includes pantothenic acid itself, its derivatives (panthenol, pantethine, pantetheine, coenzyme A, etc.) and their salts (alkali metal salts such as sodium salts; group 2 elements such as calcium salts). etc.), and in the present invention, these can be used alone or in combination of two or more.
"Vitamin B6" includes pyridoxine, pyridoxamine, pyridoxal itself, their derivatives (pyridoxal phosphate, etc.) and their derivatives (salts with Group 2 elements such as calcium salts; inorganic acid salts such as hydrochloride, etc.) ) are also included, and in the present invention, these can be used alone or in combination of two or more.
"Vitamin B7" includes not only biotin itself but also its salts (alkali metal salts such as sodium salts, etc.), and in the present invention, these can be used alone or in combination of two or more.
"Vitamin B9" includes not only folic acid itself, but also its derivatives (dihydrofolic acid, tetrahydrofolic acid, etc.) and their salts, and in the present invention, these can be used alone or in combination of two or more. can.
"Vitamin B12" includes not only cyanocobalamin and hydroxocobalamin themselves, but also their derivatives (mecobalamin, deoxyadenosylcobalamin, etc.) and their salts (inorganic acid salts such as hydrochloride; organic acid salts such as acetate). In the present invention, these can be used alone or in combination of two or more.
These B group vitamins are known, and commercially available ones may be used, or they can be produced by known methods.
In the present invention, the vitamin B group is preferably one or more selected from the group consisting of vitamin B2 and vitamin B6, from the viewpoint of suppressing the precipitation of cinnamon bark or its extract, riboflavin phosphate, pyridoxine, and the like. Particularly preferred is one or more salts selected from the group consisting of salts.

The content of vitamin B group in the oral pharmaceutical composition of the present invention is preferably 0.001 to 10% by mass based on the total mass of the oral pharmaceutical composition, from the viewpoint of suppressing precipitation of cinnamon bark or its extract. , more preferably 0.005 to 5% by mass, even more preferably 0.01 to 1% by mass, particularly preferably 0.02 to 0.05% by mass.

In addition, in the oral pharmaceutical composition of the present invention, the content ratio of cinnamon bark or an extract thereof to vitamin B group is determined based on 1 part by mass of cinnamon bark or an extract thereof, from the viewpoint of suppressing precipitation of cinnamon bark or an extract thereof. , vitamin B group is preferably 0.01 to 50 parts by weight, more preferably 0.1 to 10 parts by weight, and particularly preferably 0.2 to 1 part by weight. In addition, when the content of cinnamon bark or its extract is converted into the amount of a crude drug, from the same viewpoint, it is preferable to add 0.05 to 100 parts by mass of vitamin B group per 1 part by mass of cinnamon bark converted into a crude drug. , more preferably 0.15 to 15 parts by weight, particularly preferably 0.4 to 3 parts by weight.

If desired, the oral pharmaceutical composition of the present invention may contain pharmaceutical components other than the above-mentioned components within a range that does not impair the effects of the present invention. Such pharmaceutical ingredients include, for example, vitamin A, vitamin C, vitamin D, vitamin E, aminocarboxylic acids, sterols, calcium salts, magnesium salts, iron salts, glucuronic acids, chondroitins, sugar alcohols, Examples include one or more selected from the group consisting of glycosides, thioctic acids, crude drugs, and the like. The content of such pharmaceutical ingredients can be appropriately set within a range that does not impair the purpose of the present invention.

The oral pharmaceutical composition of the present invention is in a liquid or semi-solid form at room temperature (25°C), and specifically, it may be a solution, a colloidal solution (sol (suspension or emulsion)), or a gel. etc. The type and properties of the solvent or base for producing the oral pharmaceutical composition in such a form are not particularly limited, and may be hydrophilic or hydrophobic such as oily, and may be of different types. The solvents and bases may be mixed, emulsified, etc., as appropriate.
In the present invention, the oral pharmaceutical composition preferably contains water from the viewpoint of suppressing precipitation of cinnamon bark or an extract thereof.
The amount of water in the oral pharmaceutical composition of the present invention is not particularly limited, but from the viewpoint of taste and feeling of taking it, it is preferably 1 to 90% by mass, and preferably 5 to 70% by mass, based on the total mass of the oral pharmaceutical composition. The content is more preferably 7 to 50% by mass, and particularly preferably 9 to 30% by mass.

In addition, the viscosity of the oral pharmaceutical composition of the present invention is preferably from 500 to 10,000 mPa·s, more preferably from 1,000 to 7,000 mPa·s, and particularly preferably from 4,000 to 5,000 mPa·s, from the viewpoint of suppressing precipitate formation and fluidity. . The viscosity can be adjusted by adjusting the amount of agar mixed, water content, etc.
The viscosity is No. The measurement can be performed using a B-type viscometer equipped with three rotors under the conditions of a measurement temperature of 25° C., a rotor rotation speed of 12 rpm, and 60 seconds after the start of measurement.

In the present invention, the dosage form to which the oral pharmaceutical composition is applied is not particularly limited, and can be appropriately selected depending on the purpose of use, for example, from the dosage forms described in the 17th revised Japanese Pharmacopoeia, General Rules for Preparations, etc. can. Examples of such dosage forms include dosage forms described in the 17th edition of the Japanese Pharmacopoeia, General Rules for Preparations, such as orally administered preparations (oral liquids, syrups, oral jelly). Among these, from the viewpoint of ease of administration, oral liquid preparations and oral jelly preparations are preferable.

The oral pharmaceutical composition of the present invention may contain additives used in the pharmaceutical field, quasi-drug field, etc., depending on its dosage form, administration method, etc. Examples of such additives include sweeteners, pH adjusters, antioxidants, surfactants or emulsifiers, colorants, fragrances, corrigents, preservatives, gelling agents other than agar, and the like.

Examples of sweeteners include white sugar, glucose, fructose, invert sugar, lactose, candy powder, honey, sorbitol, maltitol, erythritol, xylitol, trehalose, sucralose, saccharin and its salts, aspartame, acesulfame potassium, stevia extract, etc. can be mentioned.
Examples of the pH adjuster include organic acids and salts thereof such as citric acid and malic acid; inorganic acids and salts thereof such as hydrochloric acid; and inorganic bases such as sodium hydroxide.
Examples of the antioxidant include ascorbic acid and its salts, erythorbic acid and its salts, edetic acid and its salts, sodium bisulfite, propyl gallate, and the like.
Examples of the surfactant or emulsifier include polysorbate, sodium lauryl sulfate, and the like.
Examples of the coloring agent include tar pigment, iron sesquioxide, caramel, and the like.
Examples of the flavor include menthol, orange, caramel, peppermint oil, vanilla flavor, mint flavor, apple flavor, ginger flavor, honey flavor, lemon flavor, and the like.
Examples of the flavoring agent include citric acid and its salts, L-glutamic acid and its salts, povidone, l-menthol, malic acid and its salts, and the like.
Examples of preservatives include benzoic acid and its salts, parabens, and the like.
Examples of gelling agents other than agar include gelatin, pectin, gellan gum, carrageenan, locust bean gum, xanthan gum, guar gum, tara gum, gum tragacanth, curdlan, sodium alginate, and dextrin.

The oral pharmaceutical composition of the present invention can be provided by being filled in a container. For example, examples include filling containers made of synthetic resin (polyethylene terephthalate, nylon, etc.), aluminum foil, glass, etc. The product may be packaged in small portions for each oral dose. Among these, it is preferable to fill a so-called pouch container such as a pouch with a spout or a T-pouch. The inside of the container may be filled with nitrogen gas from the viewpoint of quality maintenance.

In the present invention, the method for producing the oral pharmaceutical composition is not particularly limited, and may be determined depending on the types and amounts of ingredients to be mixed, properties of the composition, dosage form, usage, etc., such as the 17th edition of the Japanese Pharmacopoeia General Rules for Preparations It can be manufactured by the known method described in . For example, it can be manufactured through a process of mixing components (A) to (C) and optionally added water, other pharmaceutical ingredients, and additives, heating, and then cooling and solidifying (gelling). . Furthermore, as described above, when filling a container, the product can be manufactured through a further filling step.

EXAMPLES Hereinafter, the present invention will be explained in more detail with reference to Examples, but the present invention is not limited to these in any way.

[Test Example 1] Storage Stability Test After each sample shown below was prepared, it was stored at 80°C for 2 days. The appearance (presence or absence of precipitation) was visually evaluated before the start of storage and after storage for 2 days.
The results are shown in Table 1.

[Sample 1]
Keihi style extract (manufactured by Nippon Powder Pharmaceutical Co., Ltd., trade name Keihi style extract-Q) 50 mg (50 mg equivalent to the original crude drug), 700 mg of white sugar, 8000 mg of glucose, 500 mg of citric acid hydrate, 29 mg of sodium citrate hydrate, 4 mg of sodium benzoate , 25 mg of polysorbate 80 was dissolved and suspended in purified water to obtain Sample 1 with a total volume of 100 ml.

[Sample 2]
Sample 2 was obtained in the same manner as Sample 1, except that 50 mg of agar (manufactured by Ina Foods Co., Ltd., trade name Ina Agar PS-86k) was further added, and the solution/suspension was heated at 80° C. and then cooled.

[Sample 3]
Sample 3 was obtained in the same manner as Sample 2, except that 150 mg (2240 mg equivalent to the original drug) of dried carrot extract (trade name: Riken Dried Extract, manufactured by Riken Chemical Industries) was added.

[Sample 4]
Sample 4 was obtained in the same manner as Sample 3, except that 20 mg of riboflavin phosphate ester Na (product name: riboflavin phosphate ester manufactured by DSM) was used instead of the dried carrot extract.

[Sample 5]
Sample 5 was obtained in the same manner as Sample 3, except that 20 mg of pyridoxine hydrochloride (product name: V.B6 hydrochloride, manufactured by DSM) was used instead of the dried carrot extract.

As shown in Table 1, in sample 1, no precipitates were observed after storage at 80°C for 2 days, but in sample 2, in which agar was added to sample 1, no precipitates were observed after storage at 80°C for 2 days. was recognized.
On the other hand, in Samples 3, 4, or 5, in which dried carrot extract, Na riboflavin phosphate, or pyridoxine hydrochloride was added to Sample 2, the generation of precipitates was suppressed even after storage at 80° C. for 2 days.

From the above test results, it has become clear that the occurrence of precipitates during high-temperature storage can be suppressed by allowing carrot or its extract or vitamin B group to coexist with cinnamon bark or its extract and agar.

Production example 1 (oral liquid)
A gel-like composition containing the following components and amounts in 100 mL is produced by a conventional method, and placed in a pouch container 1 (cap: PE, pouch body: PE, aluminum) to prepare the internal liquid preparation of Production Example 1. I got it.
Riboflavin phosphate sodium 15mg
Pyridoxine hydrochloride 10mg
Nicotinic acid amide 20mg
Keihi Style Extract (Keihi Style Extract-Q) 150μl
(150mg as equivalent amount of crude drug)
Peony extract (peony extract-A) 20mg
(80mg as equivalent amount of crude drug)
Ginger style extract 600μl
(600mg as equivalent amount of crude drug)
Chimpi extract 6mg
(30mg as equivalent amount of crude drug)
Carrot extract (Riken ginseng dried extract) 67mg
(1000mg as equivalent amount of crude drug)
Royal jelly (royal jelly extract) 150μl
(100mg as equivalent amount of crude drug)
Agar end (Ina agar PS-86k) 400mg
American flour, white sugar, high fructose corn syrup, D-sorbitol, glucose, dextrin, DL-malic acid, sodium benzoate, butyl paraoxybenzoate, ethanol, l-menthol, locust bean gum, xanthan gum, fragrance (appropriate amount)

Production example 2 (internal liquid)
A gel-like composition containing the following components and quantities in 100 mL is produced by a conventional method, and placed in pouch container 1 (cap: PE, pouch body: PE, aluminum) to prepare the internal liquid preparation of Production Example 2. I got it.
Thiamine nitrate 10mg
Riboflavin phosphate sodium 15mg
Pyridoxine hydrochloride 10mg
Nicotinic acid amide 20mg
Keihi Style Extract (Keihi Style Extract-Q) 150μl
(150mg as equivalent amount of crude drug)
Peony extract (peony extract-A) 20mg
(80mg as equivalent amount of crude drug)
Ginger style extract 600μl
(600mg as equivalent amount of crude drug)
Chimpi extract 6mg
(30mg as equivalent amount of crude drug)
Carrot extract (Riken ginseng dried extract) 67mg
(1000mg as equivalent amount of crude drug)
Royal jelly (royal jelly extract) 150μl
(100mg as equivalent amount of crude drug)
Agar end (Ina agar PS-86k) 400mg
American flour, white sugar, high fructose corn syrup, D-sorbitol, glucose, dextrin, DL-malic acid, sodium benzoate, butyl paraoxybenzoate, ethanol, l-menthol, locust bean gum, xanthan gum, fragrance (appropriate amount)

Production example 3 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Tranexamic acid 250mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
Peony 25mg
(175mg as equivalent amount of crude drug)
Magnesium carbonate 135mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 4 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Tranexamic acid 250mg
Allylisopropylacetylurea 20mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
Anhydrous caffeine 80mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 5 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Tranexamic acid 250mg
Licorice extract powder 25mg
(175mg as equivalent amount of crude drug)
ginger 50mg
(300mg as equivalent amount of crude drug)
Magnesium metasilicate aluminate 100mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 6 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Allylisopropylacetylurea 20mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
Peony 25mg
(175mg as equivalent amount of crude drug)
Magnesium carbonate 135mg
Anhydrous caffeine 80mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 7 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Tranexamic acid 250mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
Licorice extract powder 25mg
(175mg as equivalent amount of crude drug)
Magnesium carbonate 135mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 8 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Allylisopropylacetylurea 20mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
ginger 50mg
(300mg as equivalent amount of crude drug)
Peony 25mg
(175mg as equivalent amount of crude drug)
Anhydrous caffeine 80mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 9 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Tranexamic acid 250mg
ginger 50mg
(300mg as equivalent amount of crude drug)
Peony 25mg
(175mg as equivalent amount of crude drug)
Magnesium metasilicate aluminate 100mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 10 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Tranexamic acid 250mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
ginger 50mg
(300mg as equivalent amount of crude drug)
Magnesium oxide 35mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Production example 11 (tablet)
Tablets containing the following ingredients and quantities in a single dose were manufactured in a conventional manner.
Loxoprofen sodium hydrate 68.1mg
Allylisopropylacetylurea 20mg
Keihi dried extract 8mg
(176mg as equivalent amount of crude drug)
Peony 25mg
(175mg as equivalent amount of crude drug)
Magnesium oxide 35mg
Anhydrous caffeine 80mg
Anhydrous calcium hydrogen phosphate, crystalline cellulose, hydrated silicon dioxide, light anhydrous silicic acid, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 6000, titanium oxide, iron sesquioxide, carnauba wax

Claims (5)

The following ingredients (A), (B) and (C):
(A) Cinnamon or its extract (B) Agar (C) One or more selected from the following ingredients (C-1) and (C-2) (C-1) Carrot or its extract (C-2) A liquid or semi-solid oral pharmaceutical composition containing B group vitamins. The oral pharmaceutical composition according to claim 1, wherein component (C-2) is one or more selected from the group consisting of vitamin B2 and vitamin B6. The oral pharmaceutical composition according to claim 1, wherein component (C-2) is one or more selected from the group consisting of riboflavin phosphate, pyridoxine, and salts thereof. The oral pharmaceutical composition according to claim 1, which is an oral liquid or an oral jelly. An oral pharmaceutical composition packed in a pouch container, which is obtained by filling a pouch container with the oral pharmaceutical composition according to any one of claims 1 to 4.