Pharmaceutical composition

Abstract

To provide a pharmaceutical formulation capable of inhibiting discoloration of a pharmaceutical composition containing ambroxol and / or a salt thereof.SOLUTION: Discoloration can be inhibited by combining codeine, dihydrocodeine and / or a salt thereof with a pharmaceutical composition containing ambroxol and / or a salt thereof.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention relates to a pharmaceutical composition containing ambroxol and / or a salt thereof, with discoloration suppressed.

Background Art

[0002] Ambroxol hydrochloride is known as an airway lubricating expectorant and is sold in dosage forms such as tablets, oral solutions, syrups, dry syrups, coated tablets, etc. (Non-Patent Document 1).

[0003] Ambroxol and its salts are widely used, particularly for the treatment and relief of cold symptoms. Furthermore, ambroxol and its salts are formulated together with other active ingredients that contribute to the treatment and relief of cold symptoms and are also commercially available as over-the-counter cold remedies that can be kept at home.

[0004] It is known that preparations containing ambroxol and its salts have reduced stability when formulated with other active ingredients, and formulations for improving preparation stability are being studied.

[0005] For example, it is known that by including pseudoephedrine or a salt thereof in a solid composition containing ibuprofen, ambroxol, or a salt thereof, the appearance change compared to storage at 5°C after storage at 65°C for 12 days is suppressed (Patent Document 1).

[0006] It is also known that by further including magnesium oxide in a pharmaceutical composition for colds containing ibuprofen and ambroxol hydrochloride, discoloration after storage at 70°C for 24 hours is suppressed (Patent Document 2).

Prior Art Documents

Non-Patent Documents

[0007]

Non-Patent Document 1

Patent Documents

[0008]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0009] Conventional formulations for improving the stability of preparations containing ambroxol and / or its salts are limited to those in the presence of antipyretics and analgesics. On the other hand, the present inventors faced the problem that ambroxol and / or its salts discolor upon exposure to light when used alone. However, there has been insufficient consideration of pharmaceutical formulations that improve the photo-instability of ambroxol and / or its salts when used alone, regardless of the co-formulation with other components other than antipyretics and analgesics.

[0010]

Means for Solving the Problems

[0011] As a result of intensive studies, the present inventors have found that discoloration due to light is suppressed by formulating ambroxol and / or its salts with codeine, dihydrocodeine and / or their salts.

[0012] That is, the present invention provides an invention in the following aspects. Item 1. A pharmaceutical composition comprising (A) ambroxol and / or its salts, and (B) codeine, dihydrocodeine and / or their salts, and not containing an antipyretic analgesic. Item 2. The pharmaceutical composition according to Item 1, further comprising (C) tranexamic acid. Item 3. The pharmaceutical composition according to Item 1 or 2, comprising 0.06 parts by weight or more of the component (B) per 1 part by weight of the component (A). Item 4. The pharmaceutical composition according to Item 2 or 3, comprising 5 parts by weight or more of the component (C) per 1 part by weight of the component (A). Item 5. The pharmaceutical composition according to any one of Items 1 to 4, comprising (D) pseudoephedrine, methylephedrine, and / or salts thereof, and / or (E) chlorpheniramine and / or salts thereof. Item 6. The pharmaceutical composition according to any one of Items 1 to 5, comprising 0.1 to 10% by weight of the component (A). Item 7. The pharmaceutical composition according to any one of Items 1 to 6, which is a granule, fine granule, powder, troche, or tablet.

Advantages of the Invention

[0013] According to the present invention, a formulation prescription capable of suppressing discoloration of a pharmaceutical composition containing ambroxol and / or a salt thereof by light is provided.

Modes for Carrying Out the Invention

[0014] The pharmaceutical composition of the present disclosure contains (A) ambroxol and / or a salt thereof (hereinafter also referred to as the “component (A)” or “ambroxol compounds”), and (B) codeine, dihydrocodeine, and / or salts thereof (hereinafter also referred to as the “component (B)” or “codeine compounds”). The pharmaceutical composition of the present disclosure may further contain (C) tranexamic acid (hereinafter also referred to as the “component (C)”). The pharmaceutical composition of the present disclosure may further contain (D) pseudoephedrine, methylephedrine, and / or salts thereof (hereinafter also referred to as the “component (D)” or “ephedrine compounds”), and / or (E) chlorpheniramine and / or salts thereof (hereinafter also referred to as the “component (E)” or “chlorpheniramine compounds”). The pharmaceutical composition of the present disclosure can suppress discoloration by light.

[0015] Hereinafter, the pharmaceutical composition of the present disclosure will be described in detail. In this specification, a numerical range indicated by two numerical values and "~" shall include the two numerical values as the lower limit value and the upper limit value. For example, the notation of 2 to 15% by weight means 2% by weight or more and 15% by weight or less.

[0016] (A) Ambroxol derivatives The pharmaceutical composition of the present disclosure contains ambroxol (trans-4-(2-amino-3,5-dibromobenzylamino)-cyclohexanol) and / or a salt thereof as the component (A). Ambroxol compounds are components known as airway lubricating expectorants. The component (A) alone exhibits discoloration upon exposure to light, but the pharmaceutical composition of the present disclosure is suppressed from discoloring upon exposure to light.

[0017] The salt of ambroxol is not particularly limited as long as it is pharmaceutically acceptable. Examples thereof include inorganic acid salts such as hydrochloride, hydrobromide, and phosphate; organic acid salts such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate.

[0018] In the pharmaceutical composition of the present disclosure, as the component (A), one of the above components may be used alone, or a plurality of components may be used in combination. Preferably, as the component (A) in the pharmaceutical composition of the present disclosure, a salt of ambroxol is mentioned, more preferably an inorganic acid salt of ambroxol, and still more preferably hydrochloride of ambroxol.

[0019] The blending amount of the component (A) in the pharmaceutical composition of the present disclosure is not particularly limited, and an amount showing a desired pharmaceutical effect can be appropriately selected. For example, 0.1 to 10% by weight, preferably 0.4 to 7% by weight, or 0.6 to 5% by weight, more preferably 0.8 to 3% by weight, still more preferably 0.9 to 2% by weight, or 0.9 to 1.5% by weight can be mentioned.

[0020] (B) Codeine derivatives The pharmaceutical composition of the present disclosure contains codeine, dihydrocodeine, and / or their salts as component (B). Codeine compounds are components known as narcotic antitussives. By blending component (B), the pharmaceutical composition of the present disclosure can suppress discoloration caused by component (A).

[0021] The salts of codeine and dihydrocodeine are not particularly limited as long as they are pharmaceutically acceptable, and examples include phosphate salts. Further, the salts of codeine and dihydrocodeine may be solvates with water or alcohol.

[0022] As component (B), one of the above components may be used alone, or a plurality of components may be used in combination. Preferably, as component (B) in the pharmaceutical composition of the present disclosure, salts of codeine and salts of dihydrocodeine are mentioned, more preferably salts of dihydrocodeine, and even more preferably dihydrocodeine phosphate.

[0023] In the pharmaceutical composition of the present disclosure, the content of component (B) is not particularly limited and can be appropriately set according to the degree of discoloration suppression effect required. For example, the content of component (B) per 1 part by weight of component (A) is, for example, 0.06 part by weight or more. From the viewpoint of enhancing the discoloration suppression effect, it is preferably 0.1 part by weight or more, or 0.3 part by weight or more, more preferably 0.5 part by weight or more, even more preferably 0.6 part by weight or more, still more preferably 0.64 part by weight or more. The content of component (B) per 1 part by weight of component (A) is not particularly limited even at its upper limit, and examples include 8 parts by weight or less, preferably 6 parts by weight or less, 4 parts by weight or less, 2 parts by weight or less, 1 part by weight or less, or 0.8 part by weight or less.

[0024] Regarding the specific content of component (B) in the pharmaceutical composition of the present disclosure, for example, it may be 0.1% by weight or more, preferably 0.3% by weight or more, more preferably 0.5% by weight or more, and even more preferably 0.6% by weight or more. The specific content of component (B) is not particularly limited even at its upper limit, and examples include 5% by weight or less, 4% by weight or less, 3% by weight or less, 2% by weight or less, or 1% by weight or less.

[0025] (C) Tranexamic acid The pharmaceutical composition of the present disclosure can contain tranexamic acid as component (C). Tranexamic acid is a component known as an anti-hemorrhagic agent, anti-allergic agent, and anti-inflammatory agent. By further blending component (C), the discoloration inhibitory property of the pharmaceutical composition of the present disclosure can be improved.

[0026] In the pharmaceutical composition of the present disclosure, the content of component (C) is not particularly limited and can be appropriately set according to the degree of the required discoloration inhibitory effect. For example, the content of component (C) per 1 part by weight of component (A) may be, for example, 5 parts by weight or more. From the viewpoint of further enhancing the discoloration inhibitory effect, it is preferably 10 parts by weight or more, more preferably 13 parts by weight or more, and even more preferably 15 parts by weight or more. The content of component (C) per 1 part by weight of component (A) is not particularly limited even at its upper limit, and examples include 60 parts by weight or less, preferably 55 parts by weight or less, 50 parts by weight or less, or 20 parts by weight or less.

[0027] Regarding the specific content of component (C) in the pharmaceutical composition of the present disclosure, for example, it may be 5% by weight or more, preferably 7% by weight or more, more preferably 9% by weight or more, even more preferably 11% by weight or more, still more preferably 13% by weight or more, and even more preferably 15% by weight or more. The specific content of component (C) is not particularly limited even at its upper limit, and examples include 90% by weight or less, 70% by weight or less, 60% by weight or less, or 30% by weight or less.

[0028] (D) Ephedrine derivatives The pharmaceutical composition of the present disclosure can contain pseudoephedrine (1-phenyl-2-methylaminopropanol-1), methylephedrine (1-phenyl-2-dimethylaminopropanol-1), and / or salts thereof as component (D). Ephedrines are components known as bronchodilators and central cough suppressants. By further blending component (D) into the pharmaceutical composition containing component (A) and component (B), the discoloration inhibitory property can be improved.

[0029] The salts of pseudoephedrine and methylephedrine are not particularly limited as long as they are pharmaceutically acceptable. Examples include inorganic acid salts such as hydrochloride, hydrobromide, and phosphate; organic acid salts such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate.

[0030] As component (D), one of the above components may be used alone, or a plurality of components may be used in combination. Preferably, as component (D) in the pharmaceutical composition of the present disclosure, methylephedrine and its salts are included, more preferably methylephedrine salts are included, still more preferably inorganic acid salts of methylephedrine are included, and even more preferably hydrochloride of methylephedrine is included.

[0031] In the pharmaceutical composition of the present disclosure, the content of component (D) is not particularly limited and can be appropriately set according to the required degree of the discoloration inhibitory effect. For example, the content of component (D) per 1 part by weight of component (A) is, for example, 0.25 part by weight or more. From the viewpoint of further enhancing the discoloration inhibitory effect, it is preferably 1 part by weight or more, more preferably 1.3 parts by weight or more, and still more preferably 1.5 parts by weight or more. The content of component (D) per 1 part by weight of component (A) is not particularly limited even at its upper limit, but is, for example, 25 parts by weight or less, preferably 10 parts by weight or less, 5 parts by weight or less, or 2.5 parts by weight or less.

[0032] In addition, as the content of the component (D) per 1 part by weight of the component (B), for example, 1 part by weight or more can be mentioned. From the viewpoint of further enhancing the discoloration suppressing effect, preferably 1.5 parts by weight or more, more preferably 2 parts by weight or more, and still more preferably 2.3 parts by weight or more can be mentioned. The content of the component (D) per 1 part by weight of the component (B) is not particularly limited even in terms of its upper limit, but for example, 10 parts by weight or less, preferably 7 parts by weight or less, 5 parts by weight or less, or 3 parts by weight or less can be mentioned.

[0033] Regarding the specific content of the component (D) in the pharmaceutical composition of the present disclosure, for example, 0.1% by weight or more, preferably 0.5% by weight or more, 0.8% by weight or more, more preferably 1.0% by weight or more, still more preferably 1.2% by weight or more, and even more preferably 1.5% by weight or more can be mentioned. The specific content of the component (D) is not particularly limited even in terms of its upper limit, but for example, 9% by weight or less, 7% by weight or less, 5% by weight or less, 3% by weight or less, or 2.5% by weight or less can be mentioned.

[0034] (E) Chlorpheniramine derivatives The pharmaceutical composition of the present disclosure can contain chlorpheniramine (3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-yl-propan-1-amine) and / or a salt thereof as the component (E). Chlorpheniramines are components known as antihistamines. By further blending the component (E) into the pharmaceutical composition containing the components (A) and (B), the discoloration inhibitory property can be improved.

[0035] The salt of chlorpheniramine is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include inorganic acid salts such as hydrochloride, hydrobromide, and phosphate; organic acid salts such as acetate, oxalate, malonate, succinate, fumarate, maleate, lactate, malate, citrate, tartrate, and carbonate.

[0036] In the pharmaceutical composition of the present disclosure, as the component (E), one of the above components may be used alone, or a plurality of components may be used in combination. Preferably, as the component (E) in the pharmaceutical composition of the present disclosure, salts of chlorpheniramine are mentioned, more preferably organic acid salts of chlorpheniramine, and even more preferably maleate salts of chlorpheniramine.

[0037] In the pharmaceutical composition of the present disclosure, the content of the component (E) is not particularly limited and can be appropriately set according to the degree to which the discoloration suppression effect is required. For example, the content of the component (E) per 1 part by weight of the component (A) is, for example, 0.05 part by weight or more. From the viewpoint of enhancing the discoloration suppression effect, it is preferably 0.1 part by weight or more, more preferably 0.15 part by weight or more, even more preferably 0.2 part by weight or more, and still more preferably 0.25 part by weight or more. The content of the component (E) per 1 part by weight of the component (A) is not particularly limited even at its upper limit, but is, for example, 1 part by weight or less, preferably 0.6 part by weight or less, 0.4 part by weight or less, or 0.3 part by weight or less.

[0038] Also, the content of the component (E) per 1 part by weight of the component (B) is, for example, 0.025 part by weight or more. From the viewpoint of enhancing the discoloration suppression effect, it is preferably 0.1 part by weight or more, more preferably 0.2 part by weight or more, and even more preferably 0.25 part by weight or more. The content of the component (E) per 1 part by weight of the component (B) is not particularly limited even at its upper limit, but is, for example, 2.5 part by weight or less, preferably 1 part by weight or less, 0.8 part by weight or less, or 0.6 part by weight or less.

[0039] Regarding the specific content of the component (E) in the pharmaceutical composition of the present disclosure, for example, 0.01% by weight or more or 0.05% by weight or more, preferably 0.1% by weight or more, more preferably 0.2% by weight or more, and even more preferably 0.25% by weight or more can be mentioned. The specific content of the component (E) is not particularly limited even at its upper limit, but is, for example, 2% by weight or less, 1% by weight or less, 0.5% by weight or less, or 0.35% by weight or less.

[0040] Antipyretic and analgesic agent The solid pharmaceutical composition of the present disclosure does not contain an antipyretic analgesic agent so as not to impair the discoloration inhibitory effect. The antipyretic analgesic agent is not particularly limited, and examples thereof include acetaminophen, loxoprofen or its salt, ibuprofen, ethenzamide, aspirin or its salt, salicylamide, sodium salicylate, salicylamide, lactylphenetidine, salsalate, isopropylantipyrine, and the like.

[0041] Other ingredients In the pharmaceutical composition of the present disclosure, other pharmacological components may or may not be contained as necessary, in addition to the components (A) to (E) described above, as long as the effects of the present invention are not impaired. The types of pharmacological components, regardless of whether they are contained or not, are not particularly limited. For example, antacids, stomachic agents, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory analgesics (such as meloxicam or its salt, etc.), astringents, antiemetics, antitussives, expectorants, anti-inflammatory enzyme agents (such as lysozyme or its salt, bromelain, serratiopeptidase, semi-alkali protease, etc.), sedative hypnotics, antihistamines, anticholinergics, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, crude drug powders or crude drug extracts, vitamins (such as tocopherol and / or its derivatives (organic acid esters such as acetate ester, nicotinate ester, succinate ester, and / or linolenic acid ester, etc.)) and the like can be mentioned. These pharmacological components may be used alone or in combination of two or more. Also, the content of these pharmacological components may be appropriately set according to the type of pharmacological component used and / or the dosage form of the pharmaceutical composition, etc.

[0042] When the pharmaceutical composition of the present disclosure contains tocopherol and / or its derivatives, the content of tocopherol and / or its derivatives is not particularly limited, but for example, the total amount is 0.1 to 3% by weight, preferably 0.5 to 2% by weight, more preferably 0.8 to 1.5% by weight.

[0043] The pharmaceutical composition of the present disclosure may or may not contain other pharmaceutically acceptable bases and / or additives, etc. as necessary for preparing into a desired dosage form. Examples of other bases and additives regardless of whether or not they are contained include, for example, excipients, binders, disintegrants, lubricants, isotonic agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, brightening agents, water, fats and oils, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, ultraviolet absorbers, preservatives, flavoring agents, fragrances, powders, thickeners, pigments, chelating agents, etc. These bases and additives may be used alone or in combination of two or more. Also, the content of these bases and / or additives may be appropriately set according to the type of additive components used and / or the dosage form of the pharmaceutical composition, etc.

[0044] Among the above bases and additives, the pharmaceutical composition of the present disclosure preferably contains, as specific components, silicic acid and / or its salts (for example, anhydrous silicic acid, hydrated silicon dioxide, aluminum silicate, sodium silicate, magnesium silicate, magnesium aluminum metasilicate, etc.); sugars (for example, disaccharides such as sucrose, lactose, maltitol, etc.); cellulose-based additives (for example, crystalline cellulose, hydroxypropyl cellulose, hypromellose and / or its esters (organic acid esters such as phthalic acid ester, acetic acid ester and / or succinic acid ester, etc.), methyl cellulose, etc.) from the viewpoint of further enhancing the discoloration suppression effect.

[0045] When the pharmaceutical composition of the present disclosure contains silicic acid and / or its salts, the content of silicic acid and / or its salts is not particularly limited, but the total amount is, for example, 10 to 70% by weight, preferably 15 to 60% by weight, more preferably 20 to 50% by weight, still more preferably 25 to 40% by weight.

[0046] When the pharmaceutical composition of the present disclosure contains the above sugar, the content of the sugar is not particularly limited, but in total, for example, 1 to 40% by weight, preferably 10 to 30% by weight, more preferably 20 to 30% by weight can be mentioned.

[0047] When the pharmaceutical composition of the present disclosure contains a cellulose-based additive, the content of the cellulose-based additive is not particularly limited, but in total, for example, 1 to 40% by weight, preferably 5 to 30% by weight, more preferably 10 to 20% by weight can be mentioned.

[0048] Formulation and packaging The dosage form of the pharmaceutical composition of the present disclosure is not particularly limited, and it may be either a liquid preparation or a solid preparation, but preferably a solid preparation. Specific examples of solid preparations include tablets (tablets with a light-transmitting (preferably transparent) coating and uncoated tablets), troches (troches with a light-transmitting (preferably transparent) coating and troches without a coating), capsules (capsules filled with light-transmitting (preferably transparent) capsules), powders, fine granules, granules (including dry syrups). Since the pharmaceutical composition of the present disclosure is excellent in discoloration suppression or discoloration suppression and moisture absorption suppression, preferred dosage forms include tablets with a light-transmitting (preferably transparent) coating, uncoated tablets, troches with a light-transmitting (preferably transparent) coating, troches without a coating, capsules filled with light-transmitting (preferably transparent) capsules, powders, fine granules, and granules. More preferably, uncoated tablets, troches without a coating, powders, fine granules, and granules can be mentioned. Even more preferably, powders, fine granules, and granules can be mentioned.

[0049] To prepare the pharmaceutical composition of the present disclosure into the above dosage form, the components (A) and (B), and, if necessary, the components (C), (D), (E) and / or other components to be formulated can be used to formulate according to the usual pharmaceutical formulation methods employed in the pharmaceutical field.

[0050] The packaging of the pharmaceutical composition of the present disclosure is not particularly limited, and examples include PTP packaging, strip packaging, blister packaging, loose packaging, and the like. Since the pharmaceutical composition of the present disclosure is excellent in discoloration suppression, it is preferable that some or all of these packaging materials are made of a translucent (preferably transparent) plastic. Further, since the pharmaceutical composition of the present disclosure is excellent in discoloration suppression, as a preferable example of the packaging, loose packaging in which the number of times of exposure to light is large can be mentioned.

[0051] Furthermore, among the packaging materials in which the pharmaceutical composition of the present disclosure is packaged, air may be filled, or an inert gas such as nitrogen may be filled. Since the pharmaceutical composition of the present disclosure is excellent in discoloration suppression, in a preferred form, air may be filled in the packaging material.

Examples

[0052] Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples.

[0053] Test example 1 The components shown in Tables 1 and 2 were mixed in a mortar to prepare a pharmaceutical composition in the form of a powder. 13 g of the prepared pharmaceutical composition was placed in a transparent petri dish (without filling with an inert gas), covered with a glass lid, and exposed to direct sunlight for 1 week. The outside air temperature during storage was 20 to 25°C.

[0054] Three panelists scored the degree of discoloration of the pharmaceutical compositions of Comparative Example 1 on a visual analog scale (VAS) where the degree of discoloration is 10 points and no discoloration is 1 point, and the average value of these scores was derived as the "discoloration score" for each comparative example, each reference example, and each example. The larger the discoloration score, the greater the degree of discoloration and the lower the discoloration suppression, and the smaller the discoloration score, the smaller the degree of discoloration and the higher the discoloration suppression. The results are shown in Tables 1 and 2.

Table 1

[0055]

Table 2

[0056] As shown in Comparative Example 1, the pharmaceutical composition containing component (A) undergoes color change upon exposure to light. However, as shown in Example 1, by additionally formulating component (B), the color change was significantly suppressed. In addition, as shown in Comparative Example 2, the combination of component (D) and component (E) formulated in Example 1 cannot suppress the color change even when additionally formulated in the pharmaceutical composition containing component (A). Therefore, the significant color change suppression effect in Example 1 is mainly contributed by the additional formulation of component (B). Even when component (D) and / or component (E) were absent in Example 1, a significant color change suppression effect was observed, but the degree was better in Example 1. As shown in Reference Examples 1 and 2, since the combinations of component (B), component (D), and component (E), and the combination of component (D) and component (E) themselves cause color change, the significant color change suppression effect observed by additionally formulating them in the pharmaceutical composition containing component (A) was unexpected.

[0057] As shown in Example 2, by further additionally formulating component (C) in the pharmaceutical composition containing component (A) and component (B), the color change was further significantly suppressed.

[0058] Also, when ephedrine hydrochloride was replaced with pseudoephedrine hydrochloride in Examples 1 and 2, a similar color change suppression effect was obtained. When dihydrocodeine phosphate was replaced with codeine phosphate in Examples 1 and 2, a similar color change suppression effect was also obtained.

[0059] On the other hand, as shown in Reference Examples 3 and 4, although ibuprofen and acetaminophen hardly cause color change, as shown in Comparative Examples 3 and 4, when additionally formulated in the composition of Example 2, the color change became significantly stronger. This tendency of enhanced color change was similarly observed for common analgesics such as sodium loxoprofen and aspirin.

Claims

1. A pharmaceutical composition comprising (A) ambroxol and / or a salt thereof, and (B) codeine, dihydrocodeine and / or a salt thereof, and not containing an antipyretic analgesic.

2. The pharmaceutical composition according to claim 1, further comprising (C) tranexamic acid.

3. The pharmaceutical composition according to claim 1, wherein the component (B) is contained in an amount of 0.06 parts by weight or more per 1 part by weight of the component (A).

4. The pharmaceutical composition according to claim 2, wherein the component (C) is contained in an amount of 5 parts by weight or more per 1 part by weight of the component (A).

5. The pharmaceutical composition according to claim 1, comprising (D) pseudoephedrine, methylephedrine, and / or a salt thereof, and / or (E) chlorpheniramine and / or a salt thereof.

6. The pharmaceutical composition according to claim 1, wherein the component (A) is contained in an amount of 0.1 to 10% by weight.

7. The pharmaceutical composition according to claim 1, which is a granule, fine granule, powder, troche, or tablet.

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