Oral gel composition

Abstract

To provide an oral gel-like composition which comprises vitamins B1 stably and has a stable gel-like form.SOLUTION: There is provided an oral gel-like composition which comprises vitamins B1 and gellan gum, where the oral gel-like composition comprises 10 to 2000 pts.mass of gellan gum based on 1 pt.mass of vitamins B1.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to an oral gel composition containing vitamin B1. [Background technology]

[0002] Vitamin B1 is known to have various beneficial effects on the body and is widely used in orally ingested medicines, quasi-drugs, foods, and the like. The forms that are most suitable for enabling sufficient intake of vitamin B1 are tablets and beverages, but in recent years, there has been an increase in the use of fluid, viscous gel-like oral preparations. The reasons behind the adoption of such gel-type preparations are thought to include the fact that consumers prefer a form that is easy to administer or ingest and swallow, particularly in relation to the increase in the number of people with swallowing disorders due to the increase in the elderly population in developed countries, and the preference for a form that can be taken easily and in a short amount of time while reducing hunger.

[0003] A known technique similar to an oral gel preparation containing vitamin B1 is an oral jelly preparation containing 0.01 to 0.5% by weight of vitamin B1 and 0.5 to 30% by weight of chondroitin sulfate (Patent Document 1). However, this oral jelly preparation is a molded gel preparation with no fluidity, and is not a liquid or a viscous gel preparation with fluidity. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2011-231051 A Summary of the Invention [Problem to be solved by the invention]

[0005] According to the investigations of the present inventors, it is difficult to realize an oral gel composition that stably contains vitamin B1, and an oral gel composition that contains vitamin B1 and has a stable gel form, in particular one that suffers little water separation over time even under heat stress during production under acidic conditions, and has a desired stable texture (hardness), and it is even more difficult to realize an oral gel composition that stably contains vitamin B1 and also has a stable gel form.

[0006] Therefore, the present invention aims to provide an oral gel composition which stably contains vitamin B1 group, has a stable gel form, undergoes little water separation over time even under heat stress during production under acidic conditions, and has a stable texture (hardness). [Means for solving the problem]

[0007] As a result of extensive research, the inventors have discovered that the above-mentioned problems can be solved by an oral gel composition that contains vitamin B1 and gellan gum, and is characterized by containing gellan gum in a range of 10 to 2,000 parts by mass per 1 part by mass of vitamin B1, and have thus completed the present invention.

[0008] That is, the present invention includes the following aspects. [1] An oral gel composition comprising vitamin B1 and gellan gum, and containing 10 to 2,000 parts by mass of gellan gum per part by mass of vitamin B1. [2] An oral gel composition comprising vitamin B1 and gellan gum, and having a gellan gum content of less than 3.0 g / L. [3] An oral gel composition comprising vitamin B1 and gellan gum and having a pH in the range of 2.5 to 3.8. [4] The oral gel composition according to any one of the above [1] to [3], which is used as a pharmaceutical or quasi-drug. [5] The oral gel composition according to any one of [1] to [4] above, wherein the vitamin B1 compound is one or more selected from the group consisting of thiamine hydrochloride, thiamine nitrate, bisthiamine nitrate, thiamine disulfide, thiamine dicetyl sulfate, dicethiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octotiamine, shikotiamine, bis-ibuthiamine, bis-bentiamine, prosultiamine, and benfotiamine. Effect of the Invention

[0009] According to the present invention, there is provided an oral gel composition which stably contains vitamin B1 and has a stable gel form. In particular, according to the present invention, there is provided an oral gel composition which has little water separation over time and has a stable texture (hardness) even when subjected to heat load during production under acidic conditions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] term As used herein, the term "gel-like composition" refers to a fluid, viscous liquid composition, as distinguished from a gel composition, which is a solid.

[0011] Unless otherwise specified, the symbols and abbreviations used in this specification are to be understood as having the meanings commonly used in the technical field to which the present invention belongs. Unless otherwise specified, the steps, treatments, or operations described herein are carried out at room temperature. In this specification, room temperature means a temperature within the range of 10 to 35°C.

[0012] Oral gel composition The oral gel composition of the present invention contains vitamin B1 and gellan gum. The components contained in the oral gel composition of the present invention and the components that may be contained therein will be described below.

[0013] · Vitamin B 1 kind Examples of vitamin B1 used in the present invention include thiamine, bisthiamine, thiamine disulfide, dicethiamine, fursultiamine, octotiamine, sicotiamine, bis-ibutiamine, bis-bentiamine, prosultiamine, and benfotiamine, as well as their salts, solvates (e.g., hydrates), and solvates (e.g., hydrates) of salts thereof. Examples of the salts include hydrochloride, nitrate, and cetyl sulfate.

[0014] The vitamin B1 may be preferably one or more selected from the group consisting of thiamine hydrochloride, thiamine nitrate, bisthiamine nitrate, thiamine disulfide, thiamine dicetyl sulfate, dicethiamine hydrochloride, fursultiamine, fursultiamine hydrochloride, octotiamine, shikotiamine, bis-ibutiamine, bis-bentiamine, prosultiamine, and benfotiamine. The vitamin B1 group that is particularly preferably used in the present invention is fursultiamine or its hydrochloride.

[0015] The amount of vitamin B1 in the oral gel composition of the present invention is about 0.00005 to 0.5 w / v%, preferably about 0.0002 to 0.25 w / v%, more preferably about 0.0005 to 0.05 w / v%, and even more preferably about 0.001 to 0.03 w / v%, based on the total composition.

[0016] · Vitamin B 1 Active ingredients other than those in this category The oral gel composition of the present invention may further contain one or more other active ingredients other than vitamin B1, such as vitamins other than vitamin B1, amino acids, etc., which are used in medicines, quasi-drugs, health functional foods (e.g., functional foods, nutrient functional foods, foods for specified health uses), or general foods (e.g., nutritional supplements, health supplements, nutritionally adjusted foods), as long as the effects of the present invention are not impaired.

[0017] Examples of vitamins other than the vitamin B1 group include vitamin A group (e.g., retinol, retinoic acid, retinal, retinol acetate, retinol palmitate, vitamin A oil, liver oil, liver oil), vitamin B2 group [e.g., riboflavin, riboflavin derivatives (e.g., riboflavin esters such as riboflavin phosphate, riboflavin acetate, riboflavin butyrate; flavin adenine dinucleotide sodium, etc.) and salts thereof (e.g., riboflavin phosphate sodium)], vitamin B6 group [e.g., pyridoxine, pyridoxamine, pyridoxal, derivatives thereof (e.g., pyridoxine phosphate, pyridoxal phosphate hydrate, pyridoxamine phosphate, pyridoxine palmitate) and salts thereof (e.g., pyridoxine hydrochloride, pyridoxal hydrochloride, pyridoxamine dihydrochloride)], vitamin B 12 Vitamin C (e.g., ascorbic acid, magnesium ascorbyl phosphate, sodium ascorbate, calcium ascorbate, tocopherol acetate ascorbate), vitamin D (e.g., ergocalciferol, cholecalciferol), vitamin E (e.g., d-α-tocopherol succinate, dl-α-tocopherol succinate) tocopherol, dl-α-tocopherol calcium succinate, d-α-tocopherol calcium succinate, tocopherol calcium succinate, d-α-tocopherol acetate, dl-α-tocopherol acetate, d-α-tocopherol, dl-α-tocopherol), niacins (e.g., nicotinic acid, nicotinamide), pantothenic acids (e.g., panthenol, calcium pantothenate, sodium pantothenate), and other vitamins (e.g., vitamin K, biotin, folic acid, gamma-oryzanol), and combinations thereof.

[0018] Examples of the amino acids include aspartic acid (e.g., L-aspartic acid, potassium L-aspartate, sodium L-aspartate, magnesium L-aspartate, and an equal mixture of potassium and magnesium aspartate), glutamic acid (e.g., L-glutamic acid), arginine (e.g., L-arginine, L-arginine hydrochloride), tryptophan (e.g., L-tryptophan), lysine (e.g., L-lysine hydrochloride, L-lysine acetate), and the like. salts), glycine, leucine (e.g., L-leucine), isoleucine (e.g., L-isoleucine), threonine (e.g., L-threonine), cysteine ​​(e.g., L-cysteine, L-cysteine ​​hydrochloride, L-cysteine ​​hydrochloride hydrate), valine (e.g., L-valine), histidine (e.g., L-histidine, L-histidine hydrochloride, L-histidine hydrochloride hydrate), and methionine (e.g., DL-methionine), and combinations thereof.

[0019] Other examples of the other active ingredients include taurine (aminoethylsulfonic acid), ursodeoxycholic acid, carnitine chloride, orotic acid, choline orotate, gamma-oryzanol, calcium citrate, calcium glycerate, calcium gluconate, diisopropylamine dichloroacetate, calcium carbonate, precipitated calcium carbonate, calcium lactate, calcium hydrogen phosphate, calcium hydrogen phosphate anhydrous, ferrous ammonium citrate, ferrous fumarate, glucuronolactone, glucuronic acid, glucuronic acid amide, caffeine, caffeine anhydrous, sodium chondroitin sulfate, inositol, glycyrrhizic acid, sodium glycyrrhizinate, sodium gluconate, and bitartaric acid. Choline, magnesium carbonate, thioctic acid, thioctic acid amide, dehydrocholic acid, pantethine, yoke lecithin, rutin, and herbal medicines (e.g., Acacia, Fennel, Eleuthero, Coptis, Modified Dioscorea, Guarana, Licorice, Lycium, Cinnamon, Red Ginseng, Saffron, Crataegus, Dioscorea, Peony, Celastrus, Ginger, Celastrus, Crataegus, Clove, Tangerine, Angelica, Toshiki, Eucommia, Cistanche, Carrot, Garlic, Poria, Muirabuama, Saussurea, Yakuchi, Coix Seed, Longan, Rokujo, Kaiba, Cistanche, Astragalus, Astragalus, Byakuya, Royal Jelly), and combinations thereof.

[0020] The amounts of these active ingredients other than vitamin B1 are appropriately determined depending on the type, purpose, etc.

[0021] · Gellan gum In the present invention, various gellan gums can be suitably used. For example, native (HA) gellan gum, deacylated (LA) gellan gum, etc. can be used. In the case of deacylated gellan gum, it is preferable to use it in combination with an appropriate amount of calcium ions, which are generally used to gel deacylated gellan gum. Such gellan gum is commercially available, for example, various native (HA) gellan gums and deacylated (LA) gellan gums sold by San-Ei Gen FFI, Kelcogel (R) (Product name: CP Kelco US, Inc.)

[0022] As a result of extensive investigations, the present inventors have found that it is desirable to contain gellan gum in the range of 10 to 2000 parts by mass per part by mass of vitamin B1. Therefore, the content of gellan gum used in the present invention is preferably in the range of 10 to 2000 parts by mass, more preferably in the range of 15 to 1500 parts by mass, and particularly preferably in the range of 20 to 1000 parts by mass, per 1 part by mass of vitamin B1.

[0023] The content of gellan gum in the oral gel composition of the present invention is preferably less than 3.0 g / L, more preferably less than 2.8 g / L, and even more preferably 0.5 g / L to 2.5 g / L, based on the total composition.

[0024] · Added ingredients other than gellan gum The oral gel composition of the present invention may contain, in addition to the above-mentioned components, one or more other components, for example, components that can generally be added to oral gel compositions (e.g., sweeteners, flavoring agents, preservatives, flavoring agents, fragrances, refreshing agents, surfactants, solubilizers, emulsifiers, solvents, pH regulators, buffers, suspending agents, colorants, stabilizers, antifoaming agents, solubilizing agents, bitterness masking agents, and thickening agents other than gellan gum), as long as the effects of the present invention are not impaired.

[0025] Examples of sweeteners include sugars (e.g., glucose, galactose, fructose, sucrose, lactose, maltose, isomerized sugar, liquid sugar, invert liquid sugar, trehalose), polysaccharides (e.g., oligosaccharides, starch), sugar alcohols (e.g., erythritol, xylitol, maltitol, sorbitol, reduced maltose syrup, powdered reduced maltose syrup), high-intensity sweeteners (e.g., acesulfame potassium) and non-sugar sweeteners (e.g., sucralose, stevia extract, saccharin, aspartame), and combinations thereof. Examples of flavoring agents include acidulants such as citric acid or its hydrate, sodium citrate, malic acid (eg, DL-malic acid), and fruit juice, and combinations thereof. Examples of preservatives or preservatives include benzoic acid, sodium benzoate, sodium sorbate, and parabens (e.g., ethyl paraben, butyl paraben, propyl paraben), and combinations thereof. Examples of flavoring agents, fragrances, or refreshing agents include orange oil, menthol, vanillin and its derivatives (e.g., ethyl vanillin), and various flavors (e.g., strawberry flavor, cherry flavor, orange flavor, grapefruit flavor, apple flavor, lemon flavor, grape flavor, coffee flavor, black tea flavor, bitter flavor, herbal mint flavor, chocolate flavor, and herbal liquor flavor), and combinations thereof. Examples of surfactants include sucrose fatty acid esters, propylene glycol, polyoxyethylene (160) polyoxypropylene (30) glycol (poloxamer 188), polyoxyethylene hydrogenated castor oils (e.g., polyoxyethylene hydrogenated castor oil 60), polysorbate 20, and polysorbate 80, and combinations thereof. Examples of solubilizing agents include refined soybean lecithin, soybean lecithin, soybean oil, medium chain triglyceride, macrogol 4000, macrogol 6000, liquid paraffin, sucrose fatty acid ester, polyoxyethylene hydrogenated castor oils, and polysorbate 80, and combinations thereof. Examples of emulsifiers include sucrose fatty acid esters, polyoxyethylene hydrogenated castor oils, polysorbate 20, polysorbate 80, refined soybean lecithin, soybean lecithin, medium-chain triglycerides, and liquid paraffin, and combinations thereof. Examples of solvents include water (eg, purified water), ethanol, propylene glycol, olive oil, sesame oil, castor oil, soybean oil, and liquid paraffin. Examples of pH adjusters or buffers include phosphoric acid, lactic acid, acetic acid, carbonic acid and their salts, hydrochloric acid, sodium hydroxide, potassium hydroxide, citrate buffer (0.2M), and sodium bicarbonate, and combinations thereof. Examples of suspending agents include gum arabic, microcrystalline cellulose, veegum, xanthan gum, guar gum, gelatin, metolose and its salts, carmellose and its salts, and combinations thereof. Examples of coloring agents include caramel, beta-carotene, and various food dyes (e.g., Food Yellow No. 1, Food Red No. 2), and combinations thereof. Examples of stabilizers include silicone resins, glycerin, salts of edetic acid, sodium chloride, and salts of pyrosulfite, and combinations thereof. Examples of antifoaming agents include silicone resins, silicone oils, ethanol, glycerin fatty acid esters, dimethylpolysiloxane, sucrose fatty acid esters, polyoxyl stearyl acid, sorubitan fatty acid esters, sorbitan trioleate, and polysorbate 80, and combinations thereof. Examples of solubilizing agents include propylene glycol, cyclodextrin, and arginine, and combinations thereof. Examples of bitterness-masking agents include phosphatidyls [e.g., BMI-60 (product name, Kao)]. Examples of thickening agents other than gellan gum include agar, xanthan gum, and guar gum, and combinations thereof.

[0026] The amounts of these added components are appropriately set depending on the types, purposes, etc.

[0027] pH of oral gel composition The present inventors have found that, in order to provide an oral gel composition that stably contains vitamin B1 (e.g., fursultiamine or its hydrochloride) and stably maintains a gel form, the upper limit of the pH of the composition is preferably 3.8 or less, more preferably 3.6 or less, and even more preferably 3.5 or less. In addition, the inventors have found that the lower limit of the pH of the composition is preferably 2.5 or more, more preferably 2.8 or more, even more preferably 3.1 or more, and particularly preferably 3.3 or more. That is, the pH of the oral gel composition of the present invention is preferably within the range of 2.5 to 3.8, more preferably within the range of 2.5 to 3.6, and even more preferably within the range of 2.8 to 3.1.

[0028] The pH may be adjusted, for example, by using the above-mentioned pH regulator or buffer. In measuring the pH of the oral gel composition of the present invention, the composition may be finely ground using a commercially available food mixer to prepare a homogeneous solution, and then the test may be carried out according to the pH measurement method described in the Japanese Pharmacopoeia General Test Methods.

[0029] Form of oral gel composition The oral gel composition of the present invention can be suitably used, for example, as an oral liquid preparation as defined in the General Provisions for Preparations of the Japanese Pharmacopoeia, Seventeenth Edition, i.e., a "liquid or fluid, viscous gel preparation for oral administration." It is determined in light of common general technical knowledge that the preparation is not a solid preparation such as a gel, but a liquid or viscous gel preparation with flowability.

[0030] The viscosity of a gel composition can be indicated by the hardness of the gel composition, and a gel composition with a high hardness can be said to have a high viscosity. The oral gel composition of the present invention preferably has a hardness of 0.05 N or more, more preferably 0.08 N or more, and even more preferably 0.10 N or more, as measured by the test method described below. By having such a hardness, the oral gel composition of the present invention can prevent aspiration and is easy to administer or ingest. The oral gel composition of the present invention has a hardness of preferably 0.50 N or less, more preferably 0.35 N or less, and even more preferably 0.30 N or less. By having such a hardness, the oral gel composition of the present invention is easy to administer or ingest. The oral gel composition of the present invention has a hardness preferably within the range of 0.05 to 0.50 N, more preferably within the range of 0.08 to 0.35 N, and even more preferably within the range of 0.10 to 0.30 N.

[0031] The oral gel composition of the present invention is orally administered or ingested. The oral gel composition of the present invention can be used as a medicine, a quasi-drug, a health functional food (e.g., a functional food, a nutrient functional food, a food for specified health uses), or a general food (e.g., a nutritional supplement, a health supplement, a nutritionally adjusted food), etc.

[0032] The oral gel composition of the present invention has high stability in its gel form. In the present invention, the gel form having high stability means, in terms of physical properties, (1) Syneresis is suppressed even after storage under harsh conditions (e.g., high temperature, acidity, and / or long periods of time), and / or (2) This means that the loss of hardness is suppressed even after storage under harsh conditions (e.g., high temperature, acidity, and / or long periods of time). From an organoleptic point of view, this also means that the texture of the gel composition is maintained.

[0033] The amount of water separated from the gel composition and the rate of water separation are measured by the following method. <Method for measuring syneresis of gel composition> In this measurement method, a sieve with a mesh size of 2 mm [Japanese Pharmacopoeia, 17th Edition, sieve number 8.6 (2000 μm)] and a diameter of 200 mm is used. The gel composition to be tested is placed in a container and exposed to a prescribed storage condition, and then the entire content of the container is placed on a sieve with a sieve underlay, and the mass is measured and designated as A (g). Next, the sieve is tilted 45 degrees and held for 1 minute, and the mass of the liquid that falls through the sieve (separated water) is measured and designated as B (g), and the rate of water separation is calculated by the following formula. Water separation rate (%)=B(g) / A(g)×100

[0034] In the oral gel composition of the present invention, the high stability of the gel form means that the appropriate hardness of the gel composition is maintained even after storage under harsh conditions (e.g., high temperature, acidity and / or long period of time).

[0035] The oral gel composition of the present invention preferably has a ratio of hardness when stored in a refrigerator (i.e., at about 4°C) for 8 weeks to the hardness when stored at 50°C for the same period (as will be understood from this definition, the hardness ratio may exceed 100%) of preferably 65% ​​or more, more preferably 70% or more, and even more preferably 80% or more.

[0036] The hardness of the oral gel composition of the present invention is measured by the following measurement method using the gel composition remaining on the sieve as a sample in the above-mentioned method for measuring syneresis of a gel composition. <Testing method for hardness of gel composition> For this test, a material testing machine capable of measuring the compressive stress of a material through linear motion, EZ-SX (product name, Shimadzu Corporation) (load cell: 50N, test jig: universal design hood test set, software: TRAPEZIUM X Texture, temperature control device: hot and cold incubator), or an equivalent product, is used. The sample is filled into a container (diameter 40 mm, height 20 mm) to a height of 15 mm, and compressed twice with a resin circular plunger (diameter 20 mm, height 8 mm) using the material testing machine at a compression speed of 10 mm / sec and a clearance of 5 mm, and the compressive stress at that time is measured. The measurement is performed at 20±2°C. The maximum value of the compressive stress in the two compressions is taken as the hardness of the sample.

[0037] The sample in this test is the gel composition remaining on the sieve in the above-mentioned method for measuring syneresis of gel composition. Therefore, if no gel composition remains on the sieve, the hardness cannot be measured; however, as a person skilled in the art would normally understand, if no gel composition remains on the sieve, it can be reasonably assumed that the hardness is lower than the hardness of the gel composition remaining on the sieve.

[0038] In the present invention, the high stability of the hardness of the gel composition means that the texture of the composition is maintained even after storage under harsh conditions (eg, high temperature, acidity and / or long periods of time). The texture of the composition is closely related to the inhibition of syneresis and the maintenance of hardness.

[0039] Method for producing oral gel composition The oral gel composition of the present invention may be produced by adopting a known method for producing an oral gel composition. Specifically, for example, (1) mixing the gellan gum with water (e.g., purified water) and then heating to dissolve the gellan gum; (2) Mixing ingredients other than the gellan gum and water with the liquid obtained in step (1) to obtain a liquid composition. The ingredients other than the gellan gum and water may be mixed in advance, if appropriate, before being mixed with the liquid obtained in step (1).

[0040] Packaging for oral gel compositions The oral gel composition of the present invention is packaged in a manner generally used for gel compositions to be orally administered or ingested. The packaging may be carried out by a conventional method depending on the form of the composition. In particular, the oral gel composition of the present invention has a highly stable gel form even under harsh conditions, and can stably contain vitamin B1, so there are fewer restrictions on the conditions of the packaging process. Therefore, various packaging methods can be easily and suitably adopted for the oral gel composition of the present invention.

[0041] The oral gel composition can be packaged, for example, by filling a container with the liquid composition obtained by the above-mentioned method for producing an oral gel composition. A suitable example of such packaging is packaging using a pouch-type container.

[0042] The pouch-type container may be a commonly used one, for example, a container made of a film material laminated with aluminum foil and a resin film (e.g., polyethylene terephthalate, nylon, and polyethylene, and combinations thereof). The pouch-type container is a container that can be retorted sterilized, that is, a retort pouch container. The pouch-type container may be of any type, such as a standing pouch type, a gusseted pouch type, or a three-sided pouch type. The pouch-type container is preferably equipped with a spout, which allows for convenient oral administration or ingestion. The oral gel composition of the present invention enclosed in one pouch-type container has a volume within the range of, for example, 80 mL to 300 mL.

[0043] As can be understood from the above description, there is also provided an oral gel composition of the present invention that is packaged in a pouch-type container. In particular, since the oral gel composition of the present invention has a high stability in gel form even under harsh conditions and can stably contain vitamin B1, there are few restrictions on the conditions of the packaging process, and the composition can be easily and suitably packaged in a pouch-type container.

[0044] As will be understood from this, the present invention also provides a bag formulation (pouch formulation, or pouch-type formulation) comprising the oral gel composition of the present invention and a pouch-type container enclosing the oral gel composition.

[0045] The bag formulation is preferably substantially free of liquid. Specifically, in the pouch preparation, pouch-shaped preparation, or bag preparation, the amount of liquid in the entire contents is preferably 10% by mass or less, more preferably 5% by mass or less, and even more preferably 3% by mass or less. EXAMPLES

[0046] The present invention will be described in more detail below with reference to examples, but the present invention is not limited thereto. In the examples, "%" means "w / w%" unless otherwise specified.

[0047] [Example 1] An oral gel composition was prepared using the ingredients shown in Table 1 below.

[0048] [Table 1]

[0049] [Method of preparing gel composition] (1) The materials listed in Table 1, from fursultiamine hydrochloride ("TTFD" in the table) to magnesium chloride, were dissolved in purified water in amounts per bag. The pH of the resulting aqueous solution was then adjusted to any of pH 2.5, pH 2.8, pH 3.1, pH 3.4, and pH 3.8 using hydrochloric acid and sodium hydroxide as appropriate. These aqueous solutions were then heated to 50°C. (2) On the other hand, the ingredients in the table from gellan gum (deacylated (LA) gellan gum, San-Ei Gen FFI) to glucose were added to the same bag and mixed, and this mixture was added to purified water with stirring to dissolve. This solution was heated in a microwave oven until it boiled. (3) Each of the aqueous solutions obtained in (1) above was mixed with the aqueous solution obtained in (2) above, and purified water was added to make up to 100 mL. (4) The obtained solutions were filled into aluminum pouches with stoppers to obtain gel compositions with pH values ​​of 2.5, 2.8, 3.1, 3.4, and 3.8.

[0050] [Example 2] An oral gel composition was prepared using the following ingredients: [material] Thickener: Gellan gum (deacylated (LA) gellan gum, San-Ei Gen FFI) Agar (Agar Powder PS-6 (product name, Ina Food Industry)) Fursultiamine hydrochloride (hereinafter referred to as TTFD) Citrate buffer 0.2M

[0051] Per bag, 1.5 mg of fursultiamine hydrochloride (TTFD), 50 mL of citrate buffer (0.2 M) with pH 2.8, 3.1, 3.4, or 3.8, and 200 mg of gellan gum (Example 2) or 300 mg of agar (Comparative Example 1) were heated and stirred to dissolve the TTFD and gellan gum or agar, and purified water was added to make up to 100 mL. The resulting solution was filled into aluminum pouches with stoppers to obtain gel compositions with pH values ​​of 2.8, 3.1, 3.4, and 3.8.

[0052] [Test Example 1] Stability of fursultiamine hydrochloride (TTFD) The gel compositions having pH values ​​of 2.5, 2.8, 3.1, 3.4, and 3.8 produced in Example 1 were each stored at 60° C. for two weeks. The amount of TTFD after storage at 60° C. for 2 weeks was measured, and the residual rate (relative to the initial content immediately after production) was calculated. The residual rate (%) is shown in Table 2.

[0053] [Table 2]

[0054] The results in Table 2 show that a high proportion of TTFD remained at all pH levels when stored under harsh conditions at 60°C for two weeks.

[0055] [Test Example 2] Syneresis of gel composition Each gel composition was stored at 50°C and 4°C (control) for 8 weeks, and then the amount of water released was measured using the measurement method described below. The water release rate was then calculated, and the difference between the values ​​was calculated as [(water release rate after 8 weeks of storage at 50°C) - (water release rate after 8 weeks of storage at 4°C)]. The difference in the syneresis rate is shown in Table 3.

[0056] <Method for measuring syneresis of gel composition> In this measurement method, a sieve with a mesh size of 2 mm [Japanese Pharmacopoeia, 17th Edition, sieve number 8.6 (2000 μm)] and a diameter of 200 mm was used. After the gel composition to be tested was placed in a container and exposed to a specified storage condition, the entire content of the container was placed on the sieve with the sieve under it, and the mass was measured and defined as A (g). The sieve was tilted at 45 degrees and held for 1 minute, after which the mass of the liquid that fell through the sieve (separated water) was measured and designated as B (g), and the separation rate was calculated using the following formula. Water separation rate (%)=B(g) / A(g)×100

[0057] [Table 3]

[0058] The results in Table 3 show that in the gel composition of the present invention, syneresis was highly suppressed at all pH values.

[0059] [Test Example 3] Hardness of gel composition The hardness of each gel composition after storage [after 8 weeks of storage at 50°C or 4°C (control)] was measured by the following method, and the ratio (50°C / control) was calculated and shown in Table 4.

[0060] <Testing method for hardness of gel composition> For this test, we used the EZ-SX (Shimadzu Corporation) material testing machine, which is capable of measuring the compressive stress of materials through linear motion (load cell: 50N, test jig: universal design hood test set, software: TRAPEZIUM X Texture, temperature control device: hot and cold incubator). The sample was filled into a container (diameter 40 mm, height 20 mm) to a height of 15 mm, and compressed twice with a resin circular plunger (diameter 20 mm, height 8 mm) using the material testing machine at a compression speed of 10 mm / sec and a clearance of 5 mm, and the compressive stress at that time was measured. The gel was placed in a thermostatic chamber at 20°C, stabilized at 20°C, and then the measurement was performed at 20±2°C. The maximum compressive stress in the two compressions was taken as the hardness of the sample.

[0061] The hardness of the gel composition after storage [after 8 weeks of storage at 50°C or 4°C (control)] was measured by the above method, and the ratio (after 8 weeks of storage at 50°C / control) was calculated. The hardness ratios are shown in Table 4. In the table, "ND" indicates that no gel composition remained on the sieve and its hardness could not be measured, which indicates that the gel-like form of the gel composition, particularly its appropriate hardness, was not maintained at all or was hardly maintained at all.

[0062] [Table 4]

[0063] The results in Table 4 show that the oral gel composition of the present invention maintained its appropriate hardness to a high degree at all pH levels when stored under harsh conditions at 50°C for 8 weeks, compared to the gel composition of the comparative example.

[0064] Formulation Example 1 According to the formulation in Table 5, an oral gel composition (pH adjusted to 3.1) was prepared containing vitamin B1 (fursultiamine hydrochloride) and 1.5 g / L gellan gum (deacylated (LA) gellan gum, San-Ei Gen FFI), with 100 parts by mass of gellan gum per 1 part by mass of vitamin B1.

[0065] [Table 5] [Industrial Applicability]

[0066] According to the present invention, an oral gel composition is provided which contains vitamin B1 and gellan gum, and by containing gellan gum in a range of 10 to 2000 parts by mass per 1 part by mass of vitamin B1, the composition stably contains vitamin B1 and has a stable gel form.

Claims

1. Vitamin B １ and gellan gum, and also contains vitamin B １ The composition contains 10 to 2,000 parts by mass of gellan gum per 1 part by mass of the above-mentioned ingredients, and contains vitamin B １ The amount of the component (I) in the composition is about 0.00005 to 0.5 w / v % based on the total weight of the composition, the content of gellan gum is 0.5 g / L to 2.5 g / L based on the total weight of the composition, the pH is within the range of 2.5 to 3.4, and vitamin B １ 13. An oral gel composition, comprising fursultiamine or fursultiamine hydrochloride.

2. 2. The oral gel composition of claim 1, wherein the pH is within the range of 2.5 to 3.

1.

3. 3. The oral gel composition according to claim 1, which is used as a pharmaceutical or quasi-drug.

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