JP7554040B2 - Muscle mass loss inhibitor - Google Patents

Description

The present invention relates to a muscle mass loss inhibitor that can suppress the loss of muscle mass during weight loss.

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 condition in which excess fat accumulates in adipose tissue, and is known to be accompanied by various health disorders. In particular, the accumulation of visceral fat 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 has been recognized as an important issue in recent years.

The most recommended measure for reducing body fat is exercise therapy, which is expected to increase muscle mass while reducing body fat. However, it is not easy to reduce body fat through exercise therapy, as exercising on a daily basis to an extent that is effective in reducing body fat is a heavy burden.

Therefore, various body fat reducing agents that do not require exercise to reduce body fat have been reported. For example, 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) have been reported.

However, it is well known that reducing body fat without exercising will result in a corresponding reduction in muscle mass. Furthermore, a reduction in muscle mass is accompanied by a decrease in basal metabolic rate, which reduces the efficiency of body fat reduction and can even lead to rebound. Therefore, it is usually recommended that body fat-reducing agents be taken in conjunction with exercise.

Buckwheat flour (Patent Document 4) and isolated soy protein (Non-Patent Documents 1 and 2) have been reported as proteins that have the effect of reducing body fat and building muscle in order to improve obesity.

On the other hand, recent research using EMS has revealed that abdominal muscles are important for effectively reducing visceral fat (Non-Patent Document 3).

JP 2011-1333 A JP 2006-117687 A JP 2006-321772 A JP 2004-166666 A

Soy Protein Isolate and Its hydrolysate Reduce Body Fat of Dietary Obese Rats and Genetically Obese Mice (Yellow KK). Nutrition 16:349-354 Effect of dietary soy protein on carbohydrate and lipid oxidation in diabetic model mice; Soy Protein Research 2002; 5:92-98 Clinical report: Effects of combined high-frequency EMS on abdominal visceral fat area and plasma adiponectin; Anti-aging science: Journal of the Society for Cerebrovascular Anti-Aging Research 8(1), 89-94, 2016-12

However, the above proteins, which have the effect of reducing body fat and building muscle, frequently cause food allergies, and there are some subjects to whom they cannot be used.

Therefore, the present invention aims to provide a new agent that can suppress the loss of muscle mass during weight loss.

After extensive research, the inventors have newly discovered that Bofutsushosan can reduce body fat while suppressing the loss of muscle mass. Unexpectedly, they also discovered that when the amount of Zingiber officinale, one of the herbal ingredients that make up Bofutsushosan, is increased, the effect of reducing body fat is further improved while the loss of muscle mass is further suppressed. The present invention was completed based on these findings and through further research.

That is, the present invention provides the following aspects.
Item 1. An agent for suppressing muscle mass loss during weight loss, comprising bofutsushosan extract.
Item 2. The muscle mass loss inhibitor according to Item 1, which is used to inhibit loss of abdominal muscle mass.
Item 3. The muscle mass loss inhibitor according to Item 1 or 2, wherein the amount of Zingiber officinale is 1 to 5 parts by weight per 100 parts by weight of the total amount of the herbal preparation used in the production of the Bofu-tsusho-san extract.
Item 4. A presentation method for demonstrating the muscle mass loss inhibitory effect during weight loss by the muscle mass loss inhibitor according to any one of claims 1 to 3, comprising using abdominal tomographic images or illustrations thereof to show the reduction in the area of visceral fat and/or subcutaneous fat over time without substantially reducing the area of muscle.

The muscle mass loss inhibitor of the present invention can suppress the loss of muscle mass during weight loss.

The figures show CT images of a human abdomen and the measurement results of abdominal fat area and abdominal muscle area before and after taking Bofu-tsushosan extract for 12 weeks.

The muscle mass decrease inhibitor of the present invention is characterized by containing a bofu-tsushosan extract. The muscle mass decrease inhibitor of the present invention will be described in detail below.

Bofutsushosan Extract In the muscle mass decrease inhibitor of the present invention, the bofutsushosan extract inhibits muscle mass decrease during weight loss. In particular, in the muscle mass decrease inhibitor of the present invention, the bofutsushosan extract inhibits muscle mass in the abdominal area. Abdominal muscles are muscles that are photographed in abdominal tomography images, and specifically include erect spinae, lateral muscles, rectus abdominis, psoas major, and quadratus lumborum. The muscle mass decrease inhibitor of the present invention can inhibit muscle mass decrease in the erect spinae, which is the largest abdominal muscle, and therefore can efficiently obtain the muscle mass decrease inhibiting effect.

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 limitations on the amount of each herb in the herb preparation used to manufacture Bofutsushosan extract, and the amount of each herb shown in the letter exemplified above may be used, but 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 Scutellaria Root, 1.2 parts by weight of Japanese Scutellaria Root, 1.2 parts by weight of Bofufu Root, 1.2 parts by weight of Ephedra Root, 1.5 parts by weight of Rhubarb, Examples include 0.6 to 1.5 parts by weight of Boshou (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 (preferably 2 parts by weight) of Ginger, and 0.6 to 1.5 parts by weight, preferably 0.8 to 1.4 parts by weight, more preferably 1 to 1.3 parts by weight, and particularly preferably 1.2 parts by weight of Zingiber officinale. By adjusting the amount of Zingiber officinale in the herbal preparation used to produce the Bofu-tsushosan extract to fall within the above range, the effect of inhibiting muscle mass loss can be more favorably improved.

In addition, the amount of sucrose, calculated as anhydrous sodium sulfate, is preferably 1 to 1.5 parts by weight, more preferably 1.3 to 1.5 parts by weight, and particularly preferably 1.5 parts by weight, to improve the hardness and disintegration properties of the tablet when it is formed into a tablet.

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 bofu-tsushosan extract used in the present invention is one that contains 3 to 5 parts by weight, more preferably 4 to 5 parts by weight, and even more preferably 4 to 4.5 parts by weight of ginger per 100 parts by weight of the total amount of the herbal preparation. By obtaining bofu-tsushosan extract from a herbal preparation with such a high ratio of ginger, it is possible to more preferably improve the effect of inhibiting a decrease in muscle mass.

A suitable example of a herbal preparation used in the manufacture of the Bofutsushosan extract used in the present invention is one containing 3 to 6 parts by weight, preferably 4 to 6 parts by weight, more preferably 5 to 6 parts by weight, and particularly preferably 5 to 5.5 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.

In addition, a suitable example of the bofutsushosan extract used in the present invention is one containing 0.005 to 0.055 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines. 6-Gingerol is an ingredient contained in ginger. In the present invention, by using a bofutsushosan extract with a high content of 6-gingerol, it is possible to more preferably improve the muscle mass reduction inhibitory effect. From the viewpoint of more preferably improving the muscle mass reduction inhibitory effect, or from the viewpoint of improving the hardness and disintegration property of the tablet when molded into a tablet, one containing 0.02 to 0.055 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines, more preferably 0.025 to 0.055 parts by weight, even more preferably 0.03 to 0.055 parts by weight, and particularly preferably 0.040 to 0.055 parts by weight, is an example. Here, the ingredients derived from herbal medicines are ingredients extracted from the herbal medicines that constitute bofutsushosan. That is, in the case of Bofutsushosan extract powder that does not contain additives such as excipients, the weight of the extract powder is the total amount of ingredients derived from the herbal medicine, and in the case of Bofutsushosan extract powder that contains additives such as excipients, the weight of the extract powder minus the weight of the additives contained is the total amount of ingredients derived from the herbal medicine.

The 6-gingerol content in ginger varies depending on the place of origin and number of years of growth of ginger, and the extraction efficiency of 6-gingerol from ginger also varies depending on the extraction conditions. Therefore, to obtain a bofutsushosan extract containing 6-gingerol in the above ratio, the ratio of ginger in the herbal preparation and the shape of ginger used for extraction (i.e., ginger used in the herbal preparation) can be appropriately set according to the 6-gingerol content contained in ginger. For example, by setting the ratio of ginger per 100 parts by weight of the total amount of the herbal preparation to the above range, and then cutting ginger into pieces of about 1 to 8 mm cubes and subjecting them to extraction, a bofutsushosan extract containing 6-gingerol within the above content range can be suitably obtained.

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 muscle mass loss inhibitor 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 muscle mass reduction inhibitor 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, dyes, and chelating agents. 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 muscle mass loss inhibitor of the present invention may contain other nutritional components and pharmacological components as necessary in addition to the bofutsushosan 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 and the formulation form of the muscle mass loss inhibitor.

The formulation of the muscle mass decrease inhibitor of the present invention is not particularly limited as long as it can be administered orally, and examples of the formulation include solid formulations such as powders, fine granules, granules (including dry syrup), tablets, pills, capsules (soft capsules, hard capsules), etc.; semi-solid formulations such as jellies; and liquid formulations such as liquids, suspensions, syrups, etc. Among these formulations, solid formulations are preferred from the viewpoints of stability of the contained ingredients, portability, etc.

Manufacturing method To prepare the muscle mass decrease inhibitor of the present invention in the above-mentioned formulation form, the bofutsushosan extract and additives, bases, and pharmacological ingredients added as necessary may be used to prepare a formulation according to a typical formulation method adopted in the pharmaceutical field. When formulated as a tablet, the manufacturing method of the muscle mass decrease inhibitor 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 muscle mass loss inhibitor of the present invention is used for the purpose of suppressing the loss of muscle mass associated with the loss of body fat during weight loss.Therefore, the muscle mass loss inhibitor of the present invention is applied to subjects who are losing weight.The weight loss is not particularly limited as long as it is not caused by exercise, and examples of the weight loss include weight loss caused by dietary restrictions and weight loss caused by taking other diet supplements or other fat-reducing agents.

In addition, since the muscle mass loss inhibitor of the present invention can suppress the loss of abdominal muscle mass, which is important for efficiently reducing visceral fat, it is preferably used during weight loss through the reduction of visceral fat. Therefore, the muscle mass loss inhibitor of the present invention is preferably applied to subjects undergoing weight loss due to abdominal obesity caused by visceral fat.

Methods for measuring muscle mass include invasive methods such as directly measuring the weight of excised muscles, and non-invasive methods such as bioelectrical impedance analysis, X-ray CT, dual-energy X-ray absorptiometry, and nuclear magnetic resonance imaging.

Dosage and Usage: The muscle mass decrease inhibitor of the present invention is administered orally. The dosage of the muscle mass decrease inhibitor of the present invention is appropriately set according to the age, sex, constitution, etc. of the subject of administration, 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 muscle mass loss inhibitor of the present invention exerts its muscle mass loss inhibitory effect by continuous administration, it is preferable to continuously administer the muscle mass loss inhibitor of the present invention (specifically, for 4 weeks or more, preferably for 12 weeks or more).

2. Presentation method showing muscle mass loss suppression effect during weight loss As described above, the muscle mass loss suppressor of the present invention suppresses muscle mass loss during weight loss. Therefore, the present invention also provides a presentation method showing the muscle mass loss suppression effect during weight loss by the muscle mass loss suppressor of the present invention, which includes using an abdominal tomographic image or an illustration thereof to show the reduction in the area of the visceral fat area and/or subcutaneous fat area over time without substantially reducing the area of the muscle area. This makes it possible to visually and easily explain the excellent effect of the muscle mass loss suppressor of the present invention. Note that "not substantially reducing the area of the muscle area" means that the sum of the areas of the muscle areas in the muscle area or the illustration (total muscle area) is 95% or more after administration compared to before administration.

An example of a specific presentation method is the abdominal tomography image shown in Figure 1. In Figure 1, abdominal tomography images before and after taking the muscle mass loss inhibitor of the present invention are shown for comparison, and while the area of visceral fat and the area of subcutaneous fat are reduced by taking the agent, the sum of the areas of abdominal muscles such as the erect spinae, lateral muscles, rectus abdominis, psoas major, and quadratus lumborum (total muscle area) is not substantially reduced. In other words, Figure 1 shows how the area of visceral fat and/or subcutaneous fat is reduced over time by taking the muscle mass loss inhibitor of the present invention without substantially reducing the area of muscle.

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

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

Production and analysis of Bofutsushosan extract
1. Preparation of Bofutsushosan Extract Powder Each herb shown in Table 1 was finely chopped, mixed in a given amount, and finely chopped to obtain a herb preparation. Twenty times the weight of water was added to the herb preparation, and extraction was performed 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.

2. Measurement of 6-gingerol content in Bofutsushosan extract powder Approximately 1 g of Bofutsushosan extract powder was precisely weighed and placed in a stoppered centrifuge tube, 30 mL of methanol/water mixture (methanol:water volume ratio 3:1) was added, and the mixture was shaken for 20 minutes, then centrifuged to separate the extract. 30 mL of methanol/water mixture (methanol:water volume ratio 3:1) was added to the residue, and this operation was repeated twice. All the extracts were combined, and a methanol/water mixture (methanol:water volume ratio 3:1) was added to make exactly 100 mL, which was used as the sample solution. Separately, approximately 5 mg of 6-gingerol for quantification was precisely weighed and dissolved in a methanol/water mixture (methanol:water volume ratio 3:1) to make exactly 100 mL, which was used as the standard solution. 10 μL each of the sample solution and standard solution were precisely taken and measured by liquid chromatography under the following test conditions.

(Test conditions)
Detector : ultraviolet spectrophotometer (measurement wavelength: 205 nm)
Column : A stainless steel tube having an inner diameter of 4.6 mm and a length of 15 cm packed with 5 μm octadecylsilylated silica gel for liquid chromatography (COSMOSIL 5C18 MS-II (5 μm, 4.6×150 mm) (Nacalai Tesque, Inc.)).
Column temperature : constant temperature around 40°C
Mobile phase : Water/acetonitrile/phosphoric acid mixture (volume ratio of water:acetonitrile:phosphoric acid 3800:2200:1)
Flow rate : adjusted so that the retention time of 6-gingerol was approximately 19 minutes.

The amount of 6-gingerol in the sample solution was calculated according to the formula below, and the 6-gingerol content in each Bofu-tsusho-san extract powder was determined.

The results are shown in Table 2. The bofutsushosan extract obtained from a herbal preparation with a high ratio of ginger (4.29 parts by weight) per 100 parts by weight of the herbal preparation had a higher 6-gingerol content of 0.052% by weight (Production Example 2) than the bofutsushosan extract obtained from a herbal preparation with a low ratio of ginger (1.11 parts by weight) per 100 parts by weight of the herbal preparation (Production Example 1).

Test Example 1: Evaluation of the effect of suppressing muscle mass loss during weight loss in mice Mice (C57BL/6J mice, 5 weeks old, male) were fed with a high-fat diet (HFD32, CLEA Japan, Inc.) ad libitum for 4 weeks to prepare obese model mice. After measuring the weight of the obese model mice, they were divided into a total of three groups, a control group, a test group 1, and a test group 2, so that the average weight of each group was about 26 g. Each group consisted of 9 mice. In the test group 1, the obese model mice were fed a feed in which the high-fat diet was mixed with the bofutsushosan extract of Production Example 1 at 2% by weight for one month. In the test group 2, the obese model mice were fed a feed in which the high-fat diet was mixed with the bofutsushosan extract of Production Example 2 at 2% by weight for one month. In the control group, the obese model mice were fed a high-fat diet without the bofutsushosan extract for one month. There was no difference in food intake between the groups.

After one month of feeding, first, using an X-ray CT scanner for experimental animals (Latheta LCT-100, Hitachi Aloka Medical, Tokyo), under isoflurane anesthesia, cross-sectional images were taken at 1.5 mm intervals from the xiphoid process to the sacrum, and the amount of visceral fat in the abdomen was calculated using the accompanying CT image analysis software. Furthermore, based on the cross-sectional images of the sacrum, the muscle mass of the erect spinae muscle, one of the abdominal muscles, was calculated in the same way. The results are shown in the table below.

As is clear from Table 3 above, administration of Bofutsushosan extract significantly reduced visceral fat mass. Furthermore, in test group 2, which was administered Bofutsushosan extract of Production Example 2 obtained from a herbal preparation with a high ginger content, visceral fat mass was further reduced. Thus, while visceral fat mass was significantly reduced (i.e., body weight was reduced), as is clear from Table 4, there was almost no change in spinal erector muscle mass. Furthermore, when comparing the average values of spinal erector muscle mass for test group 1 and test group 2, test group 2, which was administered Bofutsushosan extract of Production Example 2 obtained from a herbal preparation with a high ginger content, had a higher visceral fat mass reduction effect (Table 4), but also had a more excellent muscle mass reduction suppression effect.

Test Example 2: Inhibition of Muscle Mass Decline in Humans Subjects in their 30s to 40s (14 men, 9 women) with a BMI of 25 or more or a waist circumference of 85 cm or more for men and 90 cm or more for women before starting the study were administered 4 tablets of 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 herbal ingredients in Bofutsushosan extract was 2.5 g per day. During the study period, no special exercise load was performed and no dietary restrictions were imposed.

Physical measurements (before, and 2, 4, 8, and 12 weeks after taking the drug) and abdominal fat area measurements (before, and 4 and 12 weeks after taking the drug) were taken before and after taking the drug.

(Physical measurements)
Body weight, BMI, body fat mass, body fat percentage, muscle mass, and muscle percentage were recorded using the body composition analyzer InBody3.2 (Biospace Corporation).

(Measurement of abdominal fat area, etc.)
Using a CT scanner (Hitachi EXA.CT Scanner System, Hitachi Medical Corporation), a cross-section of the abdomen at the navel of each subject was taken. The obtained X-ray CT image data was analyzed using fat measurement software Fat Scan to calculate the visceral fat area. The subcutaneous fat area and each muscle area were obtained.

The results of physical measurements, abdominal fat area measurements, and measurements of the sizes of various body parts are shown in the table below and in Figure 1. All measurement results in the table below are shown as the mean value ± standard deviation.

As shown in Table 5, taking Bofutsushosan extract tablets resulted in significant reductions in body weight, BMI, body fat mass, and body fat percentage, while muscle mass did not decrease and muscle percentage increased. Also, as shown in Table 6, a significant reduction in visceral fat was observed. Furthermore, as shown in Figure 1, analysis of the abdominal fat area and muscle area before and after taking Bofutsushosan extract showed that while fat area was significantly reduced, muscle area was barely reduced. It was also found that the reduction rate of visceral fat area was even more significant.

Claims (3)

Contains water extract of Bofutsushosan,
The muscle mass loss inhibitor during weight loss comprises 4 to 5 parts by weight of Zingiber officinale per 100 parts by weight of the herbal preparation used in the production of the Bofu-tsusho-san extract. The muscle mass loss inhibitor according to claim 1, which is used to inhibit loss of abdominal muscle mass. A muscle mass loss inhibitor as described in claim 1 or 2, wherein the amount of Bofu-tsusho-san per 100 weight parts of the total amount of the herbal preparation used to produce the Bofu-tsusho-san extract is 3 to 6 weight parts in terms of anhydrous sodium sulfate.