JP7554041B2 - Limb Slimming Agent - Google Patents

Description

The present invention relates to an extremity slimming agent that can reduce the circumference of at least one of the upper right arm, upper left arm, right thigh, left thigh, right calf, and left calf, which are inherently difficult to slim down.

In recent years, as food culture has become more Westernized, the amount of lipid intake by Japanese people has increased, and excess lipid intake accumulates in the body in the form of fat, causing obesity and other conditions. Obesity is a state in which fat accumulates excessively in adipose tissue, and is known to be accompanied by various health disorders. In particular, the accumulation of visceral fat seen in obesity can lead to lifestyle-related diseases such as diabetes, dyslipidemia, and hypertension through metabolic syndrome, and can further progress to arteriosclerosis, leading to serious diseases such as myocardial infarction and stroke. For this reason, reducing the amount of fat accumulated in the body is recognized as an important issue.

In recent years, various oral agents have been reported for the purpose of reducing body fat in response to obesity. Taking such oral agents is widely supported because it does not require exercise, is easy, and is easy to continue. Examples of body fat reducing agents that have been reported include lactoferrin (Patent Document 1), which suppresses fat accumulation and reduces visceral fat by breaking down accumulated fat, tea extracts that promote the burning of body fat (Patent Document 2), and citrus fruit extracts that have anti-obesity effects and lipolytic activity (Patent Document 3).

However, when reducing body fat without exercise, it is common knowledge that while it is easy to achieve a reduction in body fat in the waist and hips, which are the trunk of the body, the limbs are prone to getting cold and have a relatively poor metabolism, so no effect can be expected in reducing body fat. Therefore, people who wish to slim down their limbs currently do so by exercising their limbs, rather than taking conventional oral medications aimed at reducing body fat.

JP 2011-1333 A JP 2006-117687 A JP 2006-321772 A

The object of the present invention is to provide an agent capable of slimming the limbs.

After extensive research, the inventors discovered that Bofutsushosan can effectively slim down the extremities, which are difficult to slim down by nature. The present invention was completed based on this knowledge and further research.

That is, the present invention provides the following aspects.
Item 1. A limb slimming agent containing bofu-tsusho-san extract and used for reducing the circumference of at least one of the right upper arm, the left upper arm, the right thigh, the left thigh, the right calf, and the left calf.
Item 2. The limb slimming agent according to Item 1, which is a body shape improving agent.
Item 3. The limb slimming agent according to Item 1 or 2, which is further used to reduce waist and/or hip circumference.
Item 4. A presentation method for demonstrating the limb slimming effect of the limb slimming agent according to any one of Items 1 to 3, comprising using a human body image or a human silhouette image to show the reduction in thickness of at least one of the upper arm, left upper arm, right thigh, left thigh, right calf, and left calf over time.

The limb slimming agent of the present invention can effectively slim the limbs. In addition, by using the slimming agent of the present invention to slim the limbs, which are inherently difficult to slim down, it is possible to improve the body shape.

FIG. 1 is a graph showing the reduction in limb thickness and improvement in body shape in humans before and after taking Bofutsushosan extract.

1. Limb Slimming Agent The limb slimming agent of the present invention is characterized by containing Bofu-tsusho-san extract. The limb slimming agent of the present invention will be described in detail below.

In the limb slimming agent of the present invention, the bofutsushosan extract can reduce the circumference of at least one of the limbs that are inherently difficult to slim down, that is, the right upper arm, the left upper arm, the right thigh, the left thigh, the right calf, and the left calf. The bofutsushosan extract of the present invention can also suppress the decrease in muscle mass, so that the body fat of the limbs can be reduced to achieve slimming.

According to the "Guide to General Kampo Prescriptions" (supervised by the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare, edited by the Kampo Specialist Committee of the Japan Pharmaceutical Manufacturers Association, and published by Yakugyo Jihosha), the herbal medicines that make up Bofutsushosan are Angelica Root, Peony Root, Cnidium Root, Sanshishi, Forsythia Root, Mint, Ginger Root, Cabbage Root, Bougainvillea Root, Ephedra Root, Rhubarb, Byakujutsu, Platycodon Root, Scutellaria Root, Licorice Root, Scutellaria Root, and Catharanthus Radix. Some letters do not include Byakujutsu (for example, "Experience Kampo Prescription Quantities Collection," supervised by Otsuka Keisetsu and Yakazu Domyo, published by Ido no Nihonsha), and some do not include Scutellaria Root (for example, "Zoku Kampo Arekore," compiled by Osaka Yomiuri Shimbun, published by Naniwasha). The Bofutsushosan extract used in the present invention may be obtained from any of these Bofutsushosan.

According to the "Guide to General Kampo Prescriptions" (supervised by the Ministry of Health, Labor and Welfare's Pharmaceutical Affairs Bureau, edited by the Kampo Specialist Committee of the Japan Pharmaceutical Manufacturers Association, and published by Yakugyo Jihosha) and the "17th Revised Japanese Pharmacopoeia," the amounts of each herb that makes up Bofutsushosan are as follows: Angelica acutiloba 1.2 parts by weight, Peony root 1.2 parts by weight, Cnidium rhizome 1.2 parts by weight, Gardenia japonica 1.2 parts by weight, Forsythia serrata 1.2 parts by weight, Mentha arvensis 1.2 parts by weight, and Ginger 0.3 to 1.5 parts by weight. 1.2 parts by weight, 1.2 parts by weight of Chinese holly, 1.2 parts by weight of Bougainvillea or 1.2 parts by weight of Glehnia gracilis, 1.2 parts by weight of Ephedra, 1.5 parts by weight of Rhubarb, 0.6 to 1.5 parts by weight of Bougainvillea (calculated as anhydrous sodium sulfate), 2 parts by weight of Atractylodes Root, 2 parts by weight of Platycodon Root, 2 parts by weight of Scutellaria Root, 2 parts by weight of Licorice Root, 2 to 3 parts by weight of Gypsum, and 3 to 5 parts by weight of Kasseki. Some letters also state that all of the 1.2 parts by weight in the above amounts are 1.5 parts by weight (for example, "Meikai Kampo Prescriptions," co-authored by Nishioka Kazuo and Takahashi Shintaro, published by Naniwasha).

There are no particular restrictions on the amount of each herb in the herb preparation used to manufacture the Bofu-tsushosan extract, and the amount of each herb shown in the letter exemplified above may be used. Suitable examples include 1.2 parts by weight of Angelica acutiloba, 1.2 parts by weight of Peony Root, 1.2 parts by weight of Cnidium Root, 1.2 parts by weight of Sanshi Fruit, 1.2 parts by weight of Forsythia Fruit, 1.2 parts by weight of Mentha Root, 1.2 parts by weight of Japanese Pear, 1.2 parts by weight of Japanese Scutellaria, 1.2 parts by weight of Japanese Scutellaria, 1.2 parts by weight of Japanese Scutellaria, 1.2 parts by weight of Japanese Scutellaria, 1.2 parts by weight of Japanese Scutellaria, 1.2 parts by weight of Japanese Scutellaria, 1.2 parts by weight of Japanese Ephedra, 1.5 parts by weight of Rhubarb, 1.2 parts by weight of Japanese Scutellaria ... Examples include 0.6 to 1.5 parts by weight of Angelica Root (converted into anhydrous sodium sulfate), 2 parts by weight of Atractylodes Root, 2 parts by weight of Platycodon Root, 2 parts by weight of Scutellaria Root, 2 parts by weight of Licorice Root, 2 to 3 parts by weight (preferably 2 parts by weight) of Gypsum, and 3 to 5 parts by weight (preferably 3 parts by weight) of Ginger, with 0.3 to 1.5 parts by weight, preferably 0.3 to 1.2 parts by weight, more preferably 0.3 to 0.4 parts by weight, and particularly preferably 0.3 parts by weight. By adjusting the amount of Ginger in the herbal preparation used to produce the Bofu-tsushosan extract to fall within the above range, the limb slimming effect can be more favorably improved.

In addition, by using an amount of sodium sulfate anhydrous equivalent of preferably 0.6 to 1 part by weight, more preferably 0.6 to 0.75 parts by weight, and particularly preferably 0.7 part by weight, the hardness and disintegration properties of the tablet can be improved when the tablet is formed.

In the present invention, the term "herb preparation used in the production of Bofutsushosan extract" refers to a raw material preparation used for extraction in the production of Bofutsushosan extract, i.e., a preparation containing a predetermined amount of herbs that constitute Bofutsushosan. In addition, the term "sodium sulfate anhydrous equivalent of Bofutsushosan" refers to the conversion of the hydrate to the anhydrous weight when sodium sulfate hydrate is used as Bofutsushosan. In addition, sodium sulfate hydrate (e.g., decahydrate) and/or sodium sulfate anhydrous is used as Bofutsushosan, and sodium sulfate anhydrous is preferably used from the viewpoint of improving the hardness and disintegrability of the tablet when it is formed into a tablet.

A suitable example of a herbal preparation used in the manufacture of the bofutsushosan extract used in the present invention is one containing 1 to 5 parts by weight, more preferably 1 to 4 parts by weight, even more preferably 1 to 3 parts by weight, and particularly preferably 1 to 2 parts by weight, of ginger per 100 parts by weight of the total amount of the herbal preparation. By obtaining the bofutsushosan extract from a herbal preparation with a low ratio of ginger in this way, it is possible to more preferably improve the visceral fat cell decomposition effect. By obtaining the bofutsushosan extract from a herbal preparation with a high ratio of ginger in this way, it is possible to more preferably improve the limb slimming effect.

A suitable example of a herbal preparation used in the manufacture of the Bofutsushosan extract used in the present invention is one containing 2 to 6 parts by weight, preferably 2 to 4 parts by weight, more preferably 2 to 3 parts by weight, and particularly preferably 2 to 2.5 parts by weight of Boshou, calculated as anhydrous sodium sulfate, per 100 parts by weight of the total amount of the herbal preparation. Although it depends on the dosage and formulation form, the inclusion of Boshou in the herbal preparation in such a ratio makes it possible to improve the hardness and disintegration properties of the tablet when it is formed into a tablet.

The bofutsushosan extract used in the present invention can be obtained by extracting the herbal preparation by a known method. The method for extracting the herbal preparation may be the same as the conventional method for extracting bofutsushosan extract, for example, by adding about 10 to 20 times the amount of water to the herbal preparation and stirring at about 80 to 100°C for about 1 to 3 hours. After extraction, the solids are removed by solid-liquid separation such as centrifugation and filtration, and if necessary, the bofutsushosan extract is obtained by subjecting it to concentration or drying treatment.

To obtain Bofutsushosan extract as an extract powder, the extract liquid from which the solids have been removed may be concentrated as necessary, and then subjected to a drying process such as spray drying, vacuum concentration drying, or freeze drying. In addition, when subjected to a drying process (particularly drying by spray drying), an excipient such as dextrin may be added to the extract liquid as necessary. Adding an excipient in this way makes it possible to shorten the drying time. The type and amount of excipient added are the same as when producing general herbal extract powders.

To obtain Bofutsushosan extract as a soft extract, the extract from which the solid components have been removed may be concentrated by vacuum concentration or the like. A suitable adsorbent (e.g., silicic anhydride, starch, etc.) may also be added to the soft extract to produce an adsorbed powder.

The bofutsushosan extract used in the present invention may be either an extract powder or a soft extract, and either extract powder or soft extract may be appropriately selected depending on the form of the limb slimming agent of the present invention. In addition, when formed into tablets, it is preferable to use an extract powder from the viewpoint of obtaining tablets with excellent hardness and disintegration properties.

Other components The limb slimming agent of the present invention may be composed of Bofutsushosan extract 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 inhibitors, preservatives, flavorings, fragrances, powders, thickeners, pigments, chelating agents, etc. These additives may be used alone or in combination of two or more. The content of these additives and bases is appropriately set according to the type of additives and bases used, the formulation form of the muscle mass reduction inhibitor, etc.

Examples of additives and bases include starch, 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, and preferred are carmellose calcium, light anhydrous silicic acid, magnesium stearate, and synthetic aluminum silicate. The content of these additives and bases is appropriately set according to the type of additive and base used.

In addition, the limb slimming agent of the present invention may contain other nutritional components and pharmacological components as necessary, in addition to the bofu-tsusho-san 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, and menthols. 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 depending on the type of components used, the formulation form of the limb slimming agent, and the like.

The dosage form of the limb slimming 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 (including dry syrup), tablets, pills, capsules (soft capsules, hard capsules), etc.; semi-solid preparations such as jellies; and liquid preparations such as liquids, suspensions, syrups, etc. Among these dosage forms, solid preparations are preferred from the viewpoints of the stability and portability of the contained ingredients.

Manufacturing method: To prepare the limb slimming agent of the present invention in the above-mentioned formulation form, the bofutsushosan extract and, if necessary, additives, bases, and pharmacological ingredients may be used to prepare a formulation according to a conventional formulation method employed in the pharmaceutical field. When formulated as a tablet, the manufacturing method of the limb slimming agent of the present invention preferably includes a granulation step of granulating the bofutsushosan extract or a bofutsushosan extract mixture mixed with additives, bases, other nutritional ingredients, and/or other pharmacological ingredients as necessary, and a tableting step of tableting the granulated product.

Uses The limb slimming agent of the present invention is used for the purpose of reducing the circumference of at least one of the limbs, that is, the right upper arm, the left upper arm, the right thigh, the left thigh, the right calf, and the left calf. Although the body trunk such as the waist and hips can be slimmed down, the limbs are inherently difficult to slim down, which tends to result in the limbs being thick. However, by slimming the limbs with the limb slimming agent of the present invention, the body shape of the thick limbs can be improved. Therefore, the limb slimming agent of the present invention is also used for the purpose of improving the body shape.

In addition, since the limb slimming agent of the present invention can effectively slim the limbs, it can be used even if the purpose is not to reduce the circumference of the waist and/or hips. Therefore, it is preferably applied to subjects who have been able to reduce body fat in the waist or hips using other fat-reducing agents or dieting, but whose limbs are still not slim, and subjects who are not obese but are aware that they have started to gain weight from their lower limbs. In addition, since the limb slimming agent of the present invention has an excellent fat mass reducing effect on subcutaneous fat and visceral fat other than the limbs, it may be used for the purpose of reducing the circumference of the waist and/or hips in addition to the limbs.

Furthermore, the limb slimming agent of the present invention can reduce body fat while suppressing a decrease in muscle mass, so in slimming the limbs, it is possible to reduce body fat while suppressing a decrease in muscle mass. For this reason, the limb slimming agent of the present invention is also preferably applied to subjects who do not exercise and subjects who are on a restricted diet.

Dosage and Usage: The limb slimming agent of the present invention is administered orally. The dosage of the limb slimming agent of the present invention is appropriately set according to the age, sex, constitution, etc. of the person to be administered, but for example, the total amount of the herbal medicine-derived components of the Bofu-tsushosan extract per person per day is about 1 to 10 g, preferably about 1.5 to 8 g, more preferably about 1.5 to 6 g, and may be taken 1 to 3 times, preferably 2 or 3 times, per day. The timing of administration is not particularly limited, and may be before, after, or between meals, but is preferably before (30 minutes before a meal) or between meals (2 hours after a meal).

In addition, since the limb slimming effect of the limb slimming agent of the present invention is achieved by continuous administration, it is preferable to take the limb slimming agent of the present invention continuously (specifically, for 4 weeks or more, preferably for 12 weeks or more).

2. Presentation method showing the limb slimming effect As described above, the limb slimming agent of the present invention reduces the circumference of at least one of the limbs, that is, the right upper arm, the left upper arm, the right thigh, the left thigh, the right calf, and the left calf. Therefore, the present invention also provides a presentation method for showing the limb slimming effect of the limb slimming agent of the present invention, which includes using a human body image or a human silhouette image to show the reduction in the thickness of at least one of the upper arm, the left upper arm, the right thigh, the left thigh, the right calf, and the left calf over time. This makes it possible to visually and easily explain the excellent effect of the limb slimming agent of the present invention.

A specific example of the presentation method is shown in Figure 1. In Figure 1, a human silhouette before taking the limb slimming agent of the present invention is shown for comparison with a human silhouette after taking the agent, showing how at least the thickness of the limbs is reduced by taking the agent. In other words, Figure 1 shows how the thickness of at least one of the upper arm, left upper arm, right thigh, left thigh, right calf, and left calf is reduced over time by taking the limb slimming agent of the present invention. Note that Figure 1 also shows how the waist and hips are reduced in addition to the limbs.

The presentation method of the present invention can be used in any means for explaining the efficacy of the limb slimming agent of the present invention described above. Such means include commercial messages, websites, product packages, etc., relating to the limb slimming agent.

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

Preparation of Bofutsushosan Extract Each herb shown in Table 1 was finely chopped, mixed in the prescribed amounts, and finely chopped to obtain a herb preparation. Twenty times the weight of water was added to the herb preparation, and extraction was carried out while stirring at about 100°C for 1 hour. The extract was then collected by centrifugation, concentrated under reduced pressure, and dried using a spray dryer to obtain Bofutsushosan extract powder.

The ginger used was cut into 1-8 mm cubes. The drying using a spray dryer was performed by dropping the extract into an atomizer rotating at 10,000 rpm and supplying hot air at 150°C.

Test Example 1: Evaluation of limb slimming effect Before starting to take the drug, subjects in their 30s to 40s (14 men and 9 women) were given 4 tablets of the Bofutsushosan extract tablets having the composition of Preparation Example 1 above, three times a day before or between meals, so that the total amount of the herbal medicine-derived ingredients of the Bofutsushosan extract per day was 2.5 g. During the test period, no special exercise load was performed, and no dietary restrictions were imposed.

Before and after taking the drug, physical measurements (before taking the drug, and after 2, 4, 8, and 12 weeks of taking the drug) and measurements of various body parts were taken. For physical measurements, a body composition analyzer, InBody3.2 (Biospace Corporation), was used to record weight, BMI, body fat mass, body fat percentage, muscle mass, and muscle percentage.

The results of physical measurements and measurements of each body part are shown in the table below. All measurement results in the table below are shown as average values ± standard deviation.

As shown in Table 2, taking Bofutsushosan extract tablets significantly reduced body weight, BMI, body fat mass, and body fat percentage, while muscle mass did not decrease and muscle percentage increased. As shown in Table 4, the circumferences of the right upper arm, left upper arm, right thigh, left thigh, right calf, and left calf were all significantly reduced, confirming effective slimming of the limbs. In addition, considering that muscle mass did not decrease in the results of Table 2, it can be inferred that the slimming of the limbs confirmed in Table 4 is due to the reduction of body fat in the limbs. As shown in Table 3, the circumferences of the waist and hips were also significantly reduced. In this way, it was found that the overall body shape was improved by slimming the limbs, which are difficult to slim down.

Claims (5)

A limb slimming agent that contains bofutsushosan extract, is administered orally, and is used to reduce the circumference of at least one of the right upper arm, the left upper arm, the right thigh, the left thigh, the right calf, and the left calf. The limb slimming agent according to claim 1, which is used to reduce the circumference of at least the right upper arm and the left upper arm. The limb slimming agent according to claim 1, which is used to reduce the circumference of at least the right thigh, the left thigh, the right calf, and the left calf. The limb slimming agent according to any one of claims 1 to 3, which is a body shape improving agent. The limb slimming agent according to any one of claims 1 to 4, which is further used to reduce waist and/or hip circumference.