Agent for improving lower limb fatigue

Abstract

To provide an internal medicine that can improve fatigue of lower limbs.SOLUTION: An agent for improving fatigue of lower limbs contains Kamishimotsuto extract. Such an agent can improve fatigue of lower limbs such as feelings of heavy or sluggish in feet or legs.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to an agent for improving lower limb fatigue. [Background technology]

[0002] The lower limbs are peripheral organs that are also characterized by being constantly under the weight of the body, and therefore prone to fatigue. This feeling of fatigue is particularly noticeable in everyday life, where the legs are easily fatigued, such as standing at work or maintaining the same posture for a long time, as well as with aging.

[0003] It has been reported that fatigue of the lower limbs is related to muscle stiffness (Non-Patent Document 1). More specifically, fatigue of the lower limbs is caused by blood congestion in the veins of the lower limbs and insufficient oxygen supply to the muscles (Non-Patent Document 2).

[0004] Methods for improving fatigue in the lower limbs include increasing blood flow or oxygen supply in the lower limbs by foot bathing (Non-Patent Documents 3 and 4) and promoting peripheral circulation and removing fatigue substances accumulated in the lower leg by massage (Non-Patent Document 2). [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] Journal of Physiological Anthropology, Vol. 15, No. 3, pp. 77-82, 2010 [Non-Patent Document 2] Japanese Journal of Nursing Research, Vol. 33, No. 1, pp. 111-120, 2010 [Non-Patent Document 3] Fundamentals of Nursing, 910-912, Lippincott, 1997. [Non-Patent Document 4] Arteriosclerosis obliterans (ASO), EB Nursing, 4(1),57-58, 2004. Summary of the Invention [Problem to be solved by the invention]

[0006] Methods to improve leg fatigue are merely symptomatic treatments and are time-consuming. Therefore, a new method that can easily improve leg fatigue by oral medication is desired.

[0007] The present invention aims to provide an oral medication that can improve fatigue in the lower limbs. [Means for solving the problem]

[0008] As a result of intensive research, the present inventors have found that an extract of a Chinese herbal medicine containing a specific herbal medicine has the effect of improving fatigue in the lower limbs. Based on this finding, the present invention was completed through further research.

[0009] That is, the present invention provides the following aspects. Item 1. A lower limb fatigue remedy containing an extract of a Chinese herbal medicine containing Angelica Root, Szechuan Gui, Peony Root, and Rehmannia Root as component herbs. Item 2. The agent for improving lower limb fatigue according to Item 1, wherein the herbal medicine is Shimotsuto. Item 3. The agent for improving lower limb fatigue according to Item 1, wherein the herbal medicine is Kamishimotsuto. Item 4. The agent for improving lower limb fatigue according to any one of Items 1 to 3, which is used for a subject who is not physically frail. Item 5. The agent for improving lower limb fatigue according to any one of Items 1 to 4, which is used by people who are aware of coldness and / or muscle stiffness in the lower limbs. Effect of the Invention

[0010] According to the present invention, an oral medication capable of improving fatigue in the lower limbs is provided. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The agent for improving lower limb fatigue of the present invention is characterized by containing an extract of a Chinese herbal medicine containing a specific herbal medicine. The agent for improving lower limb fatigue of the present invention will be described in detail below.

[0012] Active ingredient The agent for improving lower limb fatigue of the present invention contains an extract of a herbal medicine containing Angelica sinensis, Szechuan ginger, Peony root, and Rehmannia glutinosa as constituent herbal medicines. Here, Angelica sinensis refers to the root of Angelica acutiloba (Apiaceae), Szechuan ginger refers to the rhizome of Cnidium officinale (Apiaceae) that has been boiled, Peony root refers to the root of Paeonia lactiflora (Paeonia lactiflora) or the like, and Rehmannia glutinosa refers to the root of Rehmannia serrata (Scrophulariaceae) or the like.

[0013] Specific examples of the herbal medicines used in the present invention include Shimotsuto, Kamishimotsuto, Choreitogoshimotsuto, Kyukijiaoaito, Shichimotsukakanto, Unseiin, Renjuin, Juzentaihoto, Tokiinshi, Jishintsuuoto, Seiretsuhoketsuto, Jishinmeimokuto, Kamishyosankagawakyujioh, Saikoseikanto, Daibofuto, Keigakurenkyoto, Sokeikatsuto, and Senkanmeimokuto. These herbal medicines may be used alone or in combination of two or more.

[0014] In the present invention, among the above-mentioned herbal medicines, Kamishimotsuto is preferably used. Kamishimotsuto is described in the Chinese Ming Dynasty medical book "Banbyo Kaishun", and is a mixed herbal medicine containing Angelica sinensis, Szechuan ginger, Peony root, Rehmannia glutinosa, Atractylodes macrocarpa, Ophiopogon chinensis, Ginseng, Scutellaria baicalensis, Phellodendron bark, Schisandra chinensis, Coptis chinensis, Anemone rhizome, and Eucommia ulmoides. Among the herbal medicines contained in Kamishimotsuto, Atractylodes ulmoides may be substituted or used in combination with Atractylodes ulmoides (the rhizome of Asteraceae).

[0015] There are no particular restrictions on the mixing ratio of Angelica, Szechuan Rhizome, Peony Root, and Rehmannia Root in the constituent herbal medicines, but typically the ratio is 1 to 2 parts by weight, preferably 1.25 to 1.5 parts by weight, of Angelica; 0.75 to 2 parts by weight, preferably 1 to 1.5 parts by weight, of Szechuan Rhizome; 0.75 to 2 parts by weight, preferably 1 to 1.5 parts by weight, of Peony Root; and 1.2 to 4.25 parts by weight, preferably 1.5 to 4 parts by weight.

[0016] In the present invention, when Shimotsuto is used as a herbal medicine, the mixing ratio of Angelica, Szechuan Rhizome, Peony Root, and Rehmannia Root that constitute Shimotsuto is as described above, and preferably 1 part by weight of Angelica, 1 part by weight of Szechuan Rhizome, 1 part by weight of Peony Root, and 1 part by weight of Rehmannia Root.

[0017] In the present invention, when Kamishimotsuto is used as a herbal medicine, the mixing ratio of the herbs constituting Kamishimotsuto is not particularly limited, but is usually 1 to 2 parts by weight, preferably 1.25 to 1.5 parts by weight, of Angelica Root; 0.75 to 2 parts by weight, preferably 1 to 1.5 parts by weight, of Szechuan Licorice Root; 0.75 to 2 parts by weight, preferably 1 to 1.5 parts by weight, of Peony Root; 1.2 to 4.25 parts by weight, preferably 1.5 to 4 parts by weight, of Rehmannia Root; 1 to 2 parts by weight, preferably 1.5 parts by weight (in the case of Atractylodes macrocarpa, 1 to 1.5 parts by weight, preferably 1.25 parts by weight), and 1 to 3 parts by weight of Bakumonto To. parts by weight, preferably 1.25 to 2.5 parts by weight; ginseng 0.5 to 1.5 parts by weight, preferably 0.75 to 1.25 parts by weight; oxalis rhizome 0.25 to 1.5 parts by weight, preferably 0.5 to 1.25 parts by weight; Phellodendron Bark 0.5 to 1 part by weight, preferably 0.75 parts by weight; Schisandra chinensis 0.25 to 1 part by weight, preferably 0.5 to 0.75 parts by weight; Coptis Rhizome 0.5 to 1 part by weight, preferably 0.75 parts by weight; Anemone Rhizome 0.25 to 1 part by weight, preferably 0.5 to 0.75 parts by weight; and Eucommia ulmoides 0.5 to 1.5 parts by weight, preferably 0.75 to 1 part by weight.

[0018] Suitable examples of herbal medicine preparations used in the production of Kamishimotsuto extract used in the present invention include 1.5 parts by weight of Angelica Root, 1.5 parts by weight of Szechuan Rhizome, 1.5 parts by weight of Peony Root, 1.5 parts by weight of Rehmannia Root, 1.5 parts by weight of Atractylodes Rhizome, 2.5 parts by weight of Ophiopogon, 1.2 parts by weight of Ginseng, 1.25 parts by weight of Coptis Rhizome, 0.75 parts by weight of Phellodendron Bark, 0.75 parts by weight of Schisandra Root, 0.75 parts by weight of Coptis Rhizome, 0.75 parts by weight of Anemone Rhizome, and 0.75 parts by weight of Eucommia Root.

[0019] The form of the herbal medicine extract may be either a liquid extract such as a liquid extract or a soft extract, or a solid dry extract powder.

[0020] The liquid extract of the herbal medicine can be obtained by extracting the mixed herbs according to each herbal medicine and concentrating the obtained extract as necessary. The extraction solvent used in the extraction process is not particularly limited, and can be water or aqueous ethanol. The dried extract powder of the herbal medicine can be obtained by drying the liquid extract. The drying method is not particularly limited, and can be, for example, spray drying method, or a method of adding a suitable adsorbent (e.g., silicic anhydride, starch, etc.) to a soft extract with a high extract concentration to obtain an adsorbed powder.

[0021] In the present invention, the extract of the herbal medicine may be the extract prepared by the above-mentioned method, or may be commercially available. For example, the dried extract powder of Shimotsuto is Shimotsuto Extract-M (manufactured by Nippon Powder Pharmaceutical Co., Ltd.), and the dried extract powder of Kamishimotsuto is Kamishimotsuto Dried Extract (manufactured by Nippon Powder Pharmaceutical Co., Ltd.), which are known as commercial products and can be obtained commercially.

[0022] In the lower limb fatigue improving agent of the present invention, the content of the herbal medicine extract is not particularly limited as long as the effect of the present invention is exhibited, but is usually 10-100% by weight, preferably 20-90% by weight, more preferably 40-80% by weight, and even more preferably 60-70% by weight, calculated as the amount of dried extract powder of the herbal medicine extract. In the present invention, the amount of dried extract powder of the herbal medicine refers to the amount of the dried extract powder itself when using the dried extract powder of the herbal medicine, and refers to the amount of the amount remaining after removing the solvent when using the liquid extract of the herbal medicine. In addition, when the dried extract powder of the herbal medicine contains additives such as adsorbents added during production, the amount excludes the additives.

[0023] Other Ingredients The lower limb fatigue improving agent of the present invention may be composed of the extract of the above-mentioned specific herbal medicine alone, or may contain additives and bases according to the formulation. Such additives and bases are not particularly limited as long as they are pharmacologic acceptable, and examples thereof include excipients, binders, disintegrants, lubricants, isotonicity 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 protection agents, preservatives, flavorings, fragrances, powders, thickeners, dyes, chelating agents, etc. These additives may be used alone or in combination of two or more. In addition, the content of these additives and bases is appropriately set according to the type of additives and bases used, the formulation form of the lower limb fatigue improving agent, etc.

[0024] In addition, the lower limb fatigue improving agent of the present invention may contain other nutritional components or pharmacological components as necessary, in addition to the above-mentioned specific herbal medicine extract. Such nutritional components and pharmacological components are not particularly limited as long as they are pharmacologic acceptable, and examples thereof include antacids, stomachic agents, digestive agents, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedatives, hypnotics, antihistamines, caffeine, cardiac diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal extracts, vitamins, menthols, etc. These nutritional components and pharmacological components may be used alone or in combination of two or more. The content of these components is appropriately set according to the type of components used, etc.

[0025] Formulation The formulation form of the lower limb fatigue improving agent of the present invention is not particularly limited, as long as it can be administered orally, and examples thereof include solid preparations such as powders, fine granules, granules, tablets, troches, chewable tablets, capsules (soft capsules, hard capsules), and pills; semi-solid preparations such as jellies; and liquid preparations such as solutions, suspensions, and syrups, with granules being preferred.

[0026] Manufacturing method The method for producing the agent for improving lower limb fatigue of the present invention may be carried out by formulating the above-mentioned components in accordance with a conventional formulation method employed in the medical field.

[0027] Purpose The agent for improving lower limb fatigue of the present invention is used for the purpose of improving the fatigue of the lower limb. Since the fatigue of the lower limb is caused by insufficient blood flow (venous congestion of the lower limb) and insufficient oxygen supply to the muscle, the agent for improving lower limb fatigue of the present invention is preferably applied to people who have insufficient blood flow and / or insufficient oxygen supply to the muscle in the lower limb. Insufficient blood flow and / or insufficient oxygen supply to the muscle in the lower limb can be specifically recognized by coldness of the lower limb and / or muscle stiffness. Therefore, the agent for improving lower limb fatigue of the present invention is preferably applied to people who are aware of coldness and / or muscle stiffness in the lower limb, more specifically, people who feel heavy and / or sluggish legs.

[0028] Furthermore, whereas extracts of herbal medicines such as Kamishimotsuto have been used for physically weak people, the agent for improving lower limb fatigue of the present invention is preferably applied to subjects who are not physically weak, that is, healthy people, particularly those who are not physically weak and are 65 years of age or older, that is, healthy elderly people. Incidentally, physical weakness is clearly a constitution suitable for herbal medicines.

[0029] Dosage / Usage The lower limb fatigue improving agent of the present invention is used by oral administration.The dosage of the lower limb fatigue improving agent of the present invention is appropriately set according to the type of herbal medicine, the age, constitution, and symptom level of the administration subject, and for example, the dosage for humans per day is about 1000-10000mg in terms of the amount of powdered extract of the herbal medicine extract.

[0030] In the present invention, when Kamishimotsuto is used as a herbal medicine, the dosage of the lower limb fatigue improving agent is about 1500-8500mg, preferably about 2000-6500mg, more preferably about 2400-4500mg in terms of the dried extract powder amount of Kamishimotsuto extract, or about 6000-34000mg, preferably about 10000-26000mg, more preferably about 15000-18000mg in terms of the raw herbal medicine amount, and may be taken 1-3 times a day, preferably 2 or 3 times a day. There is no particular restriction on the timing of taking the drug, and it may be taken before meals, after meals, or between meals, but it is preferable to take the drug before meals (30 minutes before meals) or between meals (2 hours after meals).

[0031] Furthermore, since the effect of improving lower limb fatigue by the lower limb fatigue improvement agent of the present invention is achieved by continuous administration, it is preferable to take the lower limb fatigue improvement agent of the present invention continuously (specifically, for one week or more, preferably for two weeks or more). EXAMPLES

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

[0033] (1) Preparation of lower limb fatigue improving agent As raw herbal medicines, 1.5 parts by weight of Angelica Root, 1.5 parts by weight of Szechuan Gui, 1.5 parts by weight of Peony Root, 1.5 parts by weight of Rehmannia Root, 1.5 parts by weight of Atractylodes Rhizome, 2.5 parts by weight of Ophiopogon, 1.2 parts by weight of Ginseng, 1.25 parts by weight of Caltrop Rhizome, 0.75 parts by weight of Phellodendron Bark, 0.75 parts by weight of Schisandra Root, 0.75 parts by weight of Coptis Rhizome, 0.75 parts by weight of Anemone Rhizome, and 0.75 parts by weight of Eucommia Root were used, which were then chopped and extracted with 10 times the weight of water at about 100°C for 1 hour, followed by centrifugation to obtain an extract. Appropriate excipients were added to the extract, which was then concentrated under reduced pressure and dried using a spray dryer to obtain a powdered extract of Kamishimotsuto. The drying using the spray dryer was carried out by dropping the extract into an atomizer at a rotation speed of 10,000 rpm and supplying hot air at 150°C.

[0034] (2) Experimental method Subjects in their 20s to 40s with subjective symptoms of leg fatigue were given Kami Shimotsuto granules three times a day, one packet per time (equivalent to 16.25 g of the raw herbal mixture per day), for two weeks, and the severity of leg fatigue and its improvement effect were evaluated before and after taking the drug. These subjects lived daily lives that easily caused leg fatigue, such as standing work and / or maintaining the same posture, and were aware of the discomfort of coldness and / or muscle stiffness in the lower limbs, and complained of fatigue such as heavy and / or dull legs. Regarding the severity of leg heaviness and / or dullness before and after taking the drug, responses were given based on a 5-point scale, with 5 being "hard" and 1 being "not hard". The results are shown in Table 1.

[0035] [Table 1]

[0036] As shown by the above results, taking Kamishimotsuto extract improved fatigue such as heavy and / or sluggish legs.

Claims

1. An agent for improving lower limb fatigue (excluding cases accompanied by weakness of the lower limbs and cases accompanied by muscle weakness of the lower limbs) containing an extract of Kamishimotsuto.

2. The agent for improving lower limb fatigue according to claim 1 , which is used for subjects who are not physically frail.

3. 3. The agent for improving lower limb fatigue according to claim 1 or 2, which is used by people who are aware of coldness and / or muscle stiffness in the lower limbs.

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