Oral composition

Abstract

To provide a pharmaceutical formulation that can reduce unpleasant odors of an oral composition containing a high proportion of powdered Japanese valerian.SOLUTION: An oral composition contains powdered Japanese valerian of 10 wt.% or more. The oral composition is blended with powdered Cnidium rhizome, resulting in reduction of strong unpleasant odors peculiar to powdered Japanese valerian.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention relates to an oral composition containing a high content of <plant name> powder while reducing the strong unpleasant odor peculiar to <plant name> powder.

Background Art

[0002] <plant name> is a perennial plant of the family Ranunculaceae, which has been listed in the first edition of the Japanese Pharmacopoeia to date and has been used as a crude drug for a long time. The characteristic of <plant name> as a crude drug lies in its sedative effect, and it was once a central drug for treating mental and neurological diseases in the history of psychotropic and nerve drugs (Non-Patent Document 1). Currently, <plant name> powder is formulated and used in pharmaceutical products for women (Non-Patent Document 2).

Prior Art Documents

Non-Patent Documents

[0003] [[ID=2,2]]

Non-Patent Document 1

Non-Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] <plant name> powder has a strong and peculiar unpleasant odor. Therefore, when formulating an oral composition by blending <plant name> powder, its blending amount is naturally limited in order to make it tolerable for ingestion.

[0005] Please note that the specific plant name "<plant name>" needs to be replaced with the actual Japanese plant name accurately in the translation. If you can provide the correct plant name, I can further optimize the translation.On the other hand, in order to further enhance the efficacy of valerian powder, it is desirable to increase the amount it is included in the formulation. However, when valerian powder was incorporated into the oral composition at a high content of 10% by weight or more, the problem arose of a significantly stronger, characteristic unpleasant odor.

[0006] To improve the palatability of oral compositions, the formulation form is generally modified. For oral compositions containing a high content of valerian powder, for example, it is conceivable to improve palatability by formulating them as sugar-coated tablets completely enclosed in a sugar coating. However, commercially available sugar-coated tablets are sometimes provided in a container without individual packaging, and if any of the sugar-coated tablets of an oral composition containing a high content of valerian powder break, the oral composition will be exposed, releasing an unpleasant odor, which may then adhere to the other sugar-coated tablets, potentially negatively impacting palatability.

[0007] Therefore, for oral compositions containing a high content of valerian powder, a formulation that can reduce unpleasant odors by means independent of the formulation form is desired.

[0008] Therefore, the present invention aims to provide a formulation that can reduce the unpleasant odor of an oral composition containing a high content of valerian powder. [Means for solving the problem]

[0009] As a result of diligent research, the inventors of this invention discovered that by combining Cnidium officinale powder with a high-content oral composition containing Valerian powder, the unpleasant odor characteristic of Valerian powder can be reduced. This invention was completed by further research based on this finding.

[0010] In other words, the present invention provides inventions in the following embodiments. Item 1. An oral composition comprising (A) 10% by weight or more of valerian powder and (B) Cnidium officinale powder. Item 2. The oral composition according to Item 1, wherein the composition contains 0.6 parts by weight or more of component (B) per 1 part by weight of component (A). Item 3. An oral composition according to item 1 or 2, containing 21 parts by weight or more of component (B) per 100 parts by weight of the total crude drug powder. Item 4. An oral composition according to any one of items 1 to 3, further comprising (C) ginseng powder. Item 5. An oral composition according to any one of items 1 to 4, which is a tablet. [Effects of the Invention]

[0011] The present invention provides a formulation that can reduce the unpleasant odor of an oral composition containing a high content of valerian powder. [Modes for carrying out the invention]

[0012] The oral composition of the present invention is characterized by comprising (A) 10% by weight or more of valerian powder (hereinafter also referred to as "component (A)") and (B) Cnidium officinale powder (hereinafter also referred to as "component (B)"). The oral composition of the present invention may further comprise (C) ginseng powder (hereinafter also referred to as "component (C)").

[0013] (A) Valerian powder The oral composition of the present invention contains valerian powder as component (A). Valerian is obtained from the roots and rhizomes of Valeriana fauriei Briquet, a plant of the Valerianaceae family, and is used as a crude drug (Japanese Pharmacopoeia) mainly for sedative purposes. Valerian is both the name of the crude drug (Japanese Pharmacopoeia) and the botanical name. Valerian powder is commercially available from companies such as Nippon Powder Pharmaceuticals Co., Ltd. and Tochimoto Tenkaido Co., Ltd.

[0014] In the oral composition of the present invention, the content of component (A) is 10% by weight or more. When the content of valerian powder in an oral composition is 10% by weight or more, the unpleasant odor characteristic of valerian powder normally becomes significantly stronger, but in the oral composition of the present invention, this characteristic unpleasant odor is effectively reduced.

[0015] In the oral composition of the present invention, the content of component (A) is preferably 10.5% by weight or more, more preferably 11% by weight or more, and even more preferably 11.4% by weight or more. The content of component (A) in the oral composition of the present invention is not particularly limited at its upper limit, and examples thereof include 25% by weight or less, preferably 20% by weight or less, and more preferably 15% by weight or less.

[0016] (B) Cnidium officinale The oral composition of the present invention contains cnidium powder as component (B). Component (B) reduces the strong unpleasant odor peculiar to the cnidium powder, which is component (A), in an oral composition containing component (A) at a high content of 10% by weight or more.

[0017] Senkyu (Kawakyu) is usually the rhizome of Cnidium officinale Makino of the Umbelliferae family, which has been scalded and is mainly used as a crude drug (Japanese Pharmacopoeia) for applications such as blood vessel tonics and women's medications. Note that Senkyu is both a crude drug name (Japanese Pharmacopoeia) and a plant name. Cnidium powder is commercially available from Nippon Powder Chemical Co., Ltd., Tohto Tenkaido Co., Ltd., etc.

[0018] In the oral composition of the present invention, the content of component (B) may be appropriately set according to the unpleasant odor reduction effect to be imparted. As the content of component (B) per 1 part by weight of component (A), examples include 0.8 part by weight or more, preferably 1 part by weight or more, more preferably 1.3 parts by weight or more, even more preferably 1.5 parts by weight or more, 3 parts by weight or more, 5 parts by weight or more, or 6 parts by weight or more. The content of component (B) per 1 part by weight of component (A) is not particularly limited at its upper limit, and an example thereof is 10 parts by weight or less. In the oral composition of the present invention, since component (B) is excellent in the effect of reducing the unpleasant odor peculiar to component (A), the unpleasant odor can be effectively reduced without using a large amount of component (B). From such a perspective, preferred examples of the content of component (B) per 1 part by weight of component (A) include 7 parts by weight or less, 4 parts by weight or less, 3 parts by weight or less, or 2 parts by weight or less. <

[0019] Also, the content of the component (B) relative to the total crude drug powder contained in the oral composition of the present invention is not particularly limited, but examples of the content of the component (B) relative to 100 parts by weight of the total crude drug powder include 21 parts by weight or more. The upper limit of the content of the component (B) relative to 100 parts by weight of the total crude drug powder is not particularly limited either, but examples include 30 parts by weight or less or 25 parts by weight or less.

[0020] Specific examples of the content of the component (B) in the oral composition of the present invention include 7% by weight or more, preferably 10% by weight or more, more preferably 15% by weight or more, still more preferably 17% by weight or more, and 80% by weight or less, 60% by weight or less, 40% by weight or less, 30% by weight or less, or 20% by weight or less.

[0021] (C) Component The oral composition of the present invention can contain carrot powder as the component (C). Although carrot powder also has a characteristic odor, it can be blended together with the component (B) for the purpose of further reducing the unpleasant odor peculiar to the component (A).

[0022] Carrot (Daucus carota L. var. sativa DC.) is the root excluding the fine roots of Panax ginseng C.A. Meyer (Panax schinseng Nees) of the Araliaceae family, or the one lightly blanched. As a crude drug (Japanese Pharmacopoeia), it is mainly used for applications such as tonic and spermatogenic drugs, digestive stimulants, antidiarrheal drugs, tranquilizers, hypoglycemic drugs, cardiotonic drugs, warming drugs, and anti-fatigue drugs. Note that carrot is both a crude drug name (Japanese Pharmacopoeia) and a plant name. Carrot is commercially available from Nippon Pharmaceutical Co., Ltd., Toho Tenkaido Co., Ltd., etc.

[0023] In the oral composition of the present invention, the content of component (C) is not particularly limited, but for example, the content of component (C) per 1 part by weight of component (A) is 0.5 parts by weight or more, preferably 0.6 parts by weight or more, and more preferably 0.65 parts by weight or more. The upper limit of the content of component (C) per 1 part by weight of component (A) is also not particularly limited, but for example, it is 6 parts by weight or less or 5.2 parts by weight or less. Furthermore, for example, the content of component (C) per 1 part by weight of component (B) is 0.3 parts by weight or more, preferably 0.4 parts by weight or more, and more preferably 0.45 parts by weight or more, and for example, it is 4 parts by weight or less or 3.2 parts by weight or less.

[0024] Specific examples of the content of component (C) in the oral composition of the present invention include, for example, 10 to 70% by weight, preferably 20 to 60% by weight.

[0025] Other ingredients The oral composition of the present invention may further contain, in addition to the above-described components (A) and (B), and optionally component (C), additives and bases depending on the formulation. The additives and bases are not particularly limited to those that are pharmaceutically acceptable, but include excipients, binders, disintegrants, lubricants, isotonic agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, glossing agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, flavoring agents, fragrances, powders, thickeners, pigments, chelating agents, and the like. These additives may be used individually or in combination of two or more. The content of these additives and bases is appropriately determined depending on the type of additive and base used, the formulation of the oral composition of the present invention, and other factors.

[0026] Examples of additives and bases include starch, lactose, carmellose calcium, light anhydrous silicic acid, magnesium stearate, synthetic aluminum silicate, magnesium aluminometasilicate, calcium silicate, magnesium silicate, synthetic hydrotalcite, anhydrous calcium hydrogen phosphate, carmellose, croscarmellose sodium, sodium starch glycolate, and crospovidone, with magnesium stearate and synthetic aluminum silicate being preferred. The content of these additives and bases is appropriately set depending on the type of additive and base used.

[0027] If the oral composition of the present invention further contains the above-mentioned additives and bases, the total amount of the additives and bases in the oral composition may be, for example, 5 to 15% by weight, preferably 8 to 12% by weight. If the oral composition of the present invention contains magnesium stearate, its content may be, for example, 0.1 to 1% by weight, preferably 0.3 to 0.7% by weight. If the oral composition of the present invention contains synthetic aluminum silicate, its content may be 4 to 16% by weight, preferably 7 to 12% by weight, more preferably 9 to 11% by weight.

[0028] Furthermore, the oral composition of the present invention may optionally contain other nutritional components or pharmacological components. Such nutritional components or pharmacological components are not particularly limited to the extent that they are pharmaceutically acceptable, but examples include antacids, stomachic agents, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedatives and hypnotics, antihistamines, caffeines, cardiotonic and diuretic agents, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, crude drug powders and / or crude drug extracts other than the above components (A) to (C), vitamins, etc. These nutritional components or pharmacological components may be used individually or in combination of two or more. The content of these components will be appropriately determined depending on the type of component used.

[0029] Formulation The formulation form of the oral composition of the present invention is not particularly limited as long as it can be administered orally, but examples include solid formulations such as powders, fine granules, granules, tablets, pills, lozenges, chewables, and capsules; semi-solid formulations such as jellies; and liquid formulations such as liquids, suspensions, and syrups.

[0030] Among these formulation forms, solid formulations are preferred, more preferably powders, granules, tablets, and pills, and even more preferably tablets. Examples of tablets include uncoated tablets and sugar-coated tablets.

[0031] Manufacturing method The method for producing the oral composition of the present invention is to use the above-mentioned herbal medicine components and formulate them according to conventional formulation methods used in the pharmaceutical field. [Examples]

[0032] The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples.

[0033] (1) Preparation of oral composition Powdered oral compositions were prepared using the formulation ratios shown in Table 1.

[0034] (2) Evaluation of odor suppression effect The prepared oral composition was spread evenly on a hexagonal balance tray, and 15 trained professional panelists brought their noses 5 cm away from the oral composition on the tray and evaluated the level of the unpleasant odor characteristic of valerian powder. The level of the unpleasant odor was scored on an 11-point scale, with 10 representing the level of unpleasant odor perceived when the unpleasant odor was only present in a powder consisting solely of valerian powder, and 0 representing the level where no unpleasant odor was perceived. The scores were then averaged. A score of 3 or less indicates that the oral composition is suitable for administration. The results are shown in Table 1.

[0035] [Table 1]

[0036] As shown in Comparative Example 1, the oral composition containing a high content of valerian powder had such a strong, unpleasant odor characteristic of valerian powder that it was unbearable to take. On the other hand, as shown in Examples 1 and 2, when Cnidium officinale powder was added to the oral composition containing a high content of valerian powder, the unpleasant odor was significantly reduced, making it suitable for administration. Furthermore, as shown in Comparative Example 2, when Angelica sinensis powder was used instead of Cnidium officinale powder, the unpleasant odor was not reduced at all. Considering this, the remarkable odor reduction effect observed in Examples 1 and 2 was recognized as a unique effect of adding Cnidium officinale powder. Thus, according to Examples 1 and 2, by adding Cnidium officinale powder to an oral composition containing a high content of valerian powder, the unpleasant odor was reduced to a level suitable for administration, and it was found that this method can be applied to all formulations. For example, it was suitable for solid formulations that are easy to carry and store, and that can be taken quickly, such as powders, granules, tablets (uncoated and sugar-coated), and pills. It was also suitable for sugar-coated tablets, which have a risk of breaking and exposing the oral composition itself.

Claims

1. An oral composition comprising (A) 10% by weight or more of valerian powder, (B) Cnidium officinale powder, and (C) ginseng powder.

2. The oral composition according to claim 1, wherein the composition contains 0.8 parts by weight or more of component (B) per 1 part by weight of component (A).

3. The oral composition according to claim 1 or 2, comprising 21 parts by weight or more of component (B) per 100 parts by weight of the total crude drug powder.

4. An oral composition according to any one of claims 1 to 3, which is a tablet.

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