Bofu-tsusho-san extract

Abstract

To provide a bofu-tsusho-san extract with an improved action of promoting the excretion of lipid into stool.SOLUTION: When a bofu-tsusho-san extract contains 6-gingerol of 0.005-0.04 pts.wt. relative to 100 pts.wt. of the total amount of herbal medicine-derived components, the bofu-tsusho-san extract has an improved action of promoting the excretion of lipid into stool.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a bofutsushosan extract that has an excellent effect of promoting the excretion of lipids into feces. [Background technology]

[0002] In recent years, with the Westernization of dietary culture, the lipid intake of Japanese people has increased. Excessive lipid intake leads to weight gain and obesity. While the adverse effects of excessive lipid intake can be ameliorated to some extent by improving the body's lipid breakdown and metabolic capacity, there are limitations to improving lipid breakdown and metabolic capacity through medication. In particular, individuals with a body fat percentage of 25% or higher and a waist size of 85 cm or larger for more than five years, as well as middle-aged and elderly individuals with a long history of obesity, have a constitution in which lipid breakdown and metabolic capacity are essentially reduced. Therefore, it is believed that improving lipid breakdown and metabolic capacity in such individuals is difficult. Therefore, increasing lipid excretion through stool may help improve or avoid health problems caused by excessive lipid intake. This is particularly effective for individuals with a constitution in which lipid breakdown and metabolic capacity are essentially reduced.

[0003] On the other hand, Bofutsushosan is known as a herbal medicine effective in reducing visceral fat and improving metabolic syndrome. The mechanism of action of Bofutsushosan has also been elucidated, including activation of heat production in brown adipocytes via the sympathetic nervous system and promotion of fat decomposition in white adipocytes (see Non-Patent Document 1). Various formulations of Bofutsushosan extract have been developed from the perspectives of improving the effect of reducing visceral fat and improving taste (e.g., Patent Documents 1 and 2).

[0004] However, there have been no reports that have actually verified that Bofutsushosan has the effect of promoting the excretion of ingested lipids into the feces. Also, it is thought that people with a constitution that is inherently impaired in lipid degradation and metabolic ability cannot expect to benefit from improved lipid degradation and metabolic ability, and so currently, they do not usually take Bofutsushosan. [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] Traditional Chinese Medicine, Vol. 37, No. 1, 2013, pp. 38-40 [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-242354 [Patent Document 2] Japanese Patent Application Laid-Open No. 2009-242330 Summary of the Invention [Problem to be solved by the invention]

[0007] The present inventors have conducted extensive research into components that promote the excretion of ingested lipids into the feces and have found that Bofutsushosan extract has an excellent effect of promoting the excretion of ingested lipids into the feces.

[0008] On the other hand, in recent years, with the increasing health consciousness, there is a demand for further enhancement of functionality in the field of medicine. Therefore, an object of the present invention is to provide a Bofu-tsushosan extract having an enhanced effect of promoting the excretion of lipids into the feces. [Means for solving the problem]

[0009] The present inventors have conducted extensive research to solve the above-mentioned problems and have found that when a bofutsushosan extract contains 0.005 to 0.04 parts by weight of 6-gingerol per 100 parts by weight of the total amount of herbal ingredients, the effect of promoting the excretion of lipids into the feces is improved. Furthermore, the present inventors have found that when the 6-gingerol content satisfies the above-mentioned range and the herbal preparation used to extract the bofutsushosan extract contains 2 to 6 parts by weight of Glauber's salt, calculated as sodium sulfate, per 100 parts by weight of the herbal preparation, the excretion-promoting effect of the bofutsushosan extract is further improved. Based on these findings and further research, the present invention was completed.

[0010] That is, the present invention provides the following aspects. Item 1. Bofutsushosan extract containing 0.005 to 0.04 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines. Item 2. The Bofutsushosan extract according to Item 1, wherein the herbal preparation used for extracting the Bofutsushosan extract contains 2 to 6 parts by weight of Bofutsushosan in terms of anhydrous sodium sulfate per 100 parts by weight of the herbal preparation. Item 3. A fecal lipid excretion promoter comprising the Bofutsushosan extract according to Item 1 or 2. Item 4. The fecal lipid excretion promoter according to Item 3, which is taken continuously for 6 days or more. Item 5. The fecal lipid excretion promoter according to Item 3 or 4, which is used for people who have had a body fat percentage of 25% or more and a waist size of 85 cm or more for 5 years or more. [Effects of the Invention]

[0011] The Bofutsushosan extract of the present invention has a strong effect of promoting the excretion of ingested lipids into the feces, and can effectively improve or avoid health problems caused by excessive lipid intake, even in people with a constitution that is essentially impaired in lipid decomposition and metabolic ability. DETAILED DESCRIPTION OF THE INVENTION

[0012] The bofu-tsushosan extract of the present invention is characterized by containing 0.005 to 0.04 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines. The bofu-tsushosan extract of the present invention will be described in detail below.

[0013] Bofutsushosan extract According to the "Guide to General Kampo Prescriptions" (supervised by the Pharmaceutical Affairs Bureau of the Ministry of Health, Labor and Welfare, edited by the Kampo Specialist Committee of the Japan Federation of Pharmaceutical Manufacturers Associations, and published by Yakugyo Jihosha), the herbal medicines that make up bofutsushosan are: Angelica Root, Peony Root, Cnidium Rhizome, Panax Root, Forsythia Fruit, Mentha Root, Ginger Root, Calyx Root, Safflower Root, Ephedra Root, Rhubarb, Bougainvillea Root, Byakujutsu Root, Platycodon Root, Scutellaria Root, Glycyrrhiza Root, Gypsum Root, and Ginseng Root. Some sources omit Byakujutsu among the above herbal medicines (e.g., "Experienced Kampo Prescription Quantities Collection," edited by Otsuka Takanori and Yakazu Michiaki, published by Ido no Nihonsha), while others omit Scutellaria Root (e.g., "Zoku Kampo Arekore," edited by Osaka Yomiuri Shimbun, published by Naniwasha). The bofutsushosan extract used in the present invention may be derived from any of these bofutsushosan, as long as the 6-gingerol content satisfies the specified range.

[0014] The bofutsushosan extract of the present invention contains 0.005 to 0.04 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines. 6-Gingerol is a component found in ginger, and conventional bofutsushosan extracts typically contain 0.05 parts by weight or more of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines. The bofutsushosan extract of the present invention has a 6-gingerol content reduced to the aforementioned range, thereby enabling more effective promotion of lipid excretion in the feces. From the perspective of more effectively promoting lipid excretion in the feces, the bofutsushosan extract preferably contains 0.007 to 0.03 parts by weight, more preferably 0.007 to 0.025 parts by weight, and particularly preferably 0.007 to 0.015 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines. Here, the ingredients derived from herbal medicines are components extracted from the herbal medicines that make up bofutsushosan. In other words, 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 total amount of ingredients derived from the herbal medicine is the weight of the extract powder minus the weight of the additives contained therein.

[0015] The 6-gingerol content in ginger varies depending on the region of origin and the number of years of growth of the 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 form of the ginger used for extraction (i.e., the ginger used in the herbal preparation) can be appropriately determined depending on the 6-gingerol content in the ginger. The amount of 6-gingerol extracted can be reduced by processing the ginger into slices about 1 to 3 mm thick and subjecting it to extraction rather than cutting it into thin strips about 1 to 8 mm square. This allows for a more suitable bofutsushosan extract containing 6-gingerol in the above ratio. For example, by setting the ratio of ginger per 100 weight parts of the total amount of the herbal preparation to the range shown in embodiment A described below and then adjusting the shape of the ginger, it is possible to suitably obtain a bofu-tsushosan extract containing 6-gingerol within the above-mentioned content range.

[0016] 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 Times), the "17th Revised Japanese Pharmacopoeia," etc., the amounts of each herb that makes up Bofutsushosan are 1.2 parts by weight of Angelica Root, 1.2 parts by weight of Peony Root, 1.2 parts by weight of Cnidium Rhizome, 1.2 parts by weight of Gardenia Fruit, 1.2 parts by weight of Forsythia Fruit, 1.2 parts by weight of Mentha Root, 0.3 to 1.2 parts by weight of Ginger Root, 1.2 parts by weight of Celastrus Root, 1.2 parts by weight of Bupleurum Root or 1.2 parts by weight of Glycyrrhiza Root, 1.2 parts by weight of Ephedra Root, 1.5 parts by weight of Rhubarb, 0.6 to 1.5 parts by weight of Atractylodes Rhizome (equivalent to anhydrous sodium sulfate), 2 parts by weight of Platycodon Root, 2 parts by weight of Scutellaria Root, 2 parts by weight of Glycyrrhiza Root, 2 to 3 parts by weight of Gemstone Root, and 3 to 5 parts by weight of Kassoku Root. In addition, some letters state that all of the 1.2 parts by weight amounts listed above are 1.5 parts by weight (for example, "Meikai Kampo Prescriptions," co-authored by Nishioka Kazuo and Takahashi Shintaro, published by Naniwasha).

[0017] The amount of each herb in the herb preparation used to manufacture Bofutsushosan extract is not particularly limited, as long as the 6-gingerol content satisfies the above range, and the amount of each herb shown in the example letter above may be used, but suitable examples include 1.2 parts by weight of Angelica Root, 1.2 parts by weight of Peony Root, 1.2 parts by weight of Cnidium Rhizome, 1.2 parts by weight of Gardenia Fruit, 1.2 parts by weight of Forsythia Fruit, 1.2 parts by weight of Mentha Root, 1.2 parts by weight of Celastrus Root, 1.2 parts by weight of Bohui, 1.2 parts by weight of Ephedra Root, and 1.2 parts by weight of Rhubarb. 5 parts by weight, Bofutsushosan extract (equivalent to anhydrous sodium sulfate) 0.6-1.5 parts, Byakujutsu Root 2 parts, Platycodon Root 2 parts, Scutellaria Root 2 parts, Licorice Root 2 parts, Gypsum Root 2-3 parts (preferably 2 parts) and Gypsum Root 3-5 parts (preferably 3 parts) by weight, and 0.3-1.5 parts, preferably 0.3-1.2 parts, more preferably 0.3-0.4 parts, and particularly preferably 0.3 parts by weight (hereinafter sometimes referred to as "Aspect A"). By adjusting the amount of Ginger in the herbal preparation used to produce the Bofutsushosan extract to fall within the above range, the 6-gingerol content can be suitably maintained within the above range, and the excretion of lipids in the feces can be more effectively promoted. In the present invention, "a medicinal 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 medicinal herbs that constitute Bofutsushosan.

[0018] In addition, a preferred example of the above-mentioned aspect A is one in which the amount of the lipids is, in terms of anhydrous sodium sulfate, preferably 0.6 to 1 part by weight, more preferably 0.6 to 0.75 parts by weight, and particularly preferably 0.7 parts by weight. By ensuring that the amount of the lipids falls within this range, it becomes possible to more effectively promote the excretion of lipids in the feces. In the present invention, when a sodium sulfate hydrate is used as the lipid, the amount of the lipids in terms of anhydrous sodium sulfate refers to the conversion of the hydrate to the anhydrous weight. In addition, as the lipids, sodium sulfate hydrate (e.g., decahydrate) and / or sodium sulfate anhydrous is used.

[0019] A suitable example of a herbal preparation to be used in the production of the bofutsushosan extract of the present invention is one containing 1 to 5 parts by weight, preferably 1 to 4 parts by weight, 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 a bofutsushosan extract from such a herbal preparation with a low ratio of ginger, the 6-gingerol content can be suitably satisfied within the above range, making it possible to more effectively promote the excretion of lipids into the feces.

[0020] A suitable example of a herbal preparation used in the production 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 Bofutsushosan per 100 parts by weight of the total amount of the herbal preparation, calculated as anhydrous sodium sulfate. By including Bofutsushosan in the herbal preparation in such a ratio, it is possible to more effectively promote the excretion of lipids into the feces. This becomes possible.

[0021] The bofutsushosan extract of the present invention can be obtained by extracting the herbal preparation using 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 or filtration, and if necessary, further concentration or drying treatment is performed to obtain the bofutsushosan extract of the present invention.

[0022] To obtain the Bofutsushosan extract of the present invention as an extract powder, the extract liquid from which the solids have been removed may be concentrated as needed, and then subjected to a drying process such as spray drying, vacuum concentration drying, or freeze drying. Furthermore, when subjected to a drying process (particularly a drying process by spray drying), an excipient such as dextrin may be added to the extract liquid as needed. 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 those used in the production of general herbal extract powders.

[0023] To obtain the Bofutsushosan extract of the present invention as a soft extract, the extract from which the solid components have been removed may be concentrated by vacuum concentration, etc. Alternatively, an appropriate adsorbent (e.g., silicic anhydride, starch, etc.) may be added to the soft extract to form an adsorbed powder.

[0024] The Bofutsushosan extract of the present invention may be either an extract powder or a soft extract.

[0025] Formulation The bofutsushosan extract of the present invention may be formulated solely with the bofutsushosan extract, or may be formulated with additives and bases to prepare a desired formulation. Such additives and bases are not particularly limited as long as they are pharmaceutically 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, flavoring agents, fragrances, powders, thickeners, pigments, 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 determined depending on the type of additives and bases used, the formulation, and the like.

[0026] Furthermore, the Bofutsushosan extract of the present invention may be formulated in combination with other nutritional components or pharmacological components, if necessary. Such nutritional components and pharmacological components are not particularly limited as long as they are pharmaceutically acceptable, and examples thereof include antacids, stomachic agents, digestive aids, 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 determined depending on the type of components used, the formulation, etc.

[0027] The formulation of the Bofutsushosan extract of the present invention is not particularly limited as long as it can be administered orally, and examples thereof 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 solutions, suspensions, syrups, etc. Among these formulations, solid formulations are preferred from the viewpoints of the stability of the ingredients contained therein, portability, etc.

[0028] To prepare the Bofutoujiosan extract of the present invention into the above-mentioned formulation, the Bofutoujiosan extract, and additives, bases, and pharmacological ingredients added as necessary, can be formulated according to conventional formulation methods used in the pharmaceutical field.

[0029] Purpose The Bofutsushosan extract of the present invention is used for purposes such as weight loss and visceral fat reduction, similar to the conventional Bofutsushosan extract, but has an excellent effect of promoting the excretion of ingested lipids into the feces, and can be suitably used as a fecal lipid excretion promoter.Furthermore, the Bofutsushosan extract of the present invention has an excellent effect of promoting the excretion of cholesterol into the feces, and can be suitably used for purposes such as promoting the excretion of ingested cholesterol or cholesterol in the blood into the feces.

[0030] Furthermore, for people with a constitution in which lipid decomposition and metabolic ability are essentially reduced, conventional Bofutsushosan extracts cannot be expected to improve lipid decomposition and metabolic ability, and it is believed that weight loss and visceral fat reduction cannot be achieved, and therefore there has been no custom of taking conventional Bofutsushosan extracts. However, the Bofutsushosan extract of the present invention promotes the excretion of lipids in the feces, thereby making it possible to suppress the adverse effects (weight gain, visceral fat increase, etc.) caused by lipid intake, even for people with a constitution in which lipid decomposition and metabolic ability are essentially reduced. In view of these effects of the present invention, suitable subjects for the Bofutsushosan extract of the present invention include people with a constitution in which lipid decomposition and metabolic ability are essentially reduced. Specific examples of people with this constitution include those who have had a body fat percentage of 25% or more and a waist size of 85 cm or more for five years or more; middle-aged or older people (45 years of age or older) who are obese (for example, a body fat percentage of 25% or more); and those who have adipose tissue with a lipolytic capacity of 5 mEq / g or less, preferably 3 mEq / g or less, more preferably 1 mEq / g or less, even more preferably 0.5 mEq / g or less, and particularly preferably 0.3 mEq / g or less, as measured in the lipolytic capacity evaluation test described below. <Lipolysis power evaluation test> First, adipose tissue was collected from the subcutaneous tissue of a subject. The obtained adipose tissue was washed with Krebs Ringer buffer (pH 7.4). The weight of the washed adipose tissue was measured, and 0.2 g of the washed adipose tissue was added to 5 mL of Krebs Ringer buffer (pH 7.4) containing 1 μg / mL noradrenaline and 2% by weight bovine serum albumin (BSA) and incubated at 37°C for 2 hours. The supernatant was then collected, and the amount of free fatty acids released into the supernatant upon noradrenaline stimulation was measured. The amount of free fatty acids released per gram of adipose tissue (mEq / g) was calculated as the lipolytic activity.

[0031] It is known that adipose tissue is activated by noradrenaline stimulation, and accumulated fat is decomposed to release free fatty acids. In the lipolytic ability evaluation test, the decomposition ability of adipose tissue is evaluated by measuring the amount of released free fatty acids.

[0032] Dosage / Usage The bofutsushosan extract of the present invention is administered orally. The dosage of the bofutsushosan extract of the present invention is appropriately determined depending on the age, sex, constitution, etc. of the recipient. For example, the bofutsushosan extract may be administered in an amount such that the total amount of herbal ingredients in the bofutsushosan extract is about 1 to 10 g, preferably about 1.5 to 8 g, more preferably about 1.5 to 6 g per person per day, 1 to 3 times a day, preferably 2 or 3 times a day. The timing of administration is not particularly limited, and may be before, after, or between meals, but is preferably before (30 minutes before) or between meals (2 hours after).

[0033] Furthermore, since the effect of the Bofutoujiosan extract of the present invention in promoting the excretion of lipids into the stool is achieved by continuous administration, it is preferable to take the Bofutoujiosan extract of the present invention continuously (specifically, for continuous administration for 6 days or more, preferably for continuous administration for 12 days or more). [Example]

[0034] The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

[0035] Production and analysis of Bofutsushosan extract 1. Manufacturing of Bofutsushosan extract powder Each of the herbal medicines shown in Table 1 was shredded or sliced, mixed in the specified amounts, and shredded to obtain a herbal medicine preparation. A 20-fold volume of water by weight was added to the herbal medicine preparation, and extraction was carried out with stirring at approximately 100°C for 1 hour. The extract was then recovered by centrifugation, concentrated under reduced pressure, and dried using a spray dryer to obtain Bofutsushosan extract powder.

[0036] In Production Examples 1 and 2, ginger was used that had been cut into 1-8 mm cubes, and ginger was used that had been sliced ​​into 1-3 mm thick slices in Production Example 3. 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.

[0037] [Table 1]

[0038] 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 a methanol / water mixture (methanol:water volume ratio 3:1) was added, and the tube was shaken for 20 minutes, then centrifuged to separate the extract. 30 mL of a methanol / water mixture (methanol:water volume ratio 3:1) was added to the residue, and this procedure was repeated twice. All extracts were combined and made up to exactly 100 mL with a methanol / water mixture (methanol:water volume ratio 3:1) to prepare the sample solution. Separately, approximately 5 mg of 6-gingerol for assay 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 of each of the sample solution and standard solution was accurately measured by liquid chromatography under the following test conditions. (Test conditions) detector :Ultraviolet absorption photometer (measurement wavelength: 205nm) column : A stainless steel tube with 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℃ mobile phase : Water / acetonitrile / phosphoric acid mixture (volume ratio of water:acetonitrile:phosphoric acid 3800:2200:1) flow rate The retention time of 6-gingerol was adjusted to approximately 19 minutes.

[0039] 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.

number

[0040] The results are shown in Table 2. In 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, the 6-gingerol content was significantly low at 0.010% by weight (Production Example 1). Furthermore, when the ginger used for extraction was sliced ​​into 1-3 mm thick slices, the 6-gingerol content in the obtained bofutsushosan extract was reduced compared to when the ginger was shredded into 1-8 mm cubes (Production Examples 2 and 3).

[0041] [Table 2]

[0042] Test Example 1: Evaluation of the effect of promoting excretion of lipids into feces and the effect of reducing body weight Obese model mice (C57BL / 6J mice, 5 weeks old, male) were maintained on a high-fat diet (HFD32, CLEA Japan, Inc.) ad libitum for 4 weeks to generate obese model mice. The weights of these obese model mice were measured and then divided into three groups (6-11 mice per group)—a control group (control example), test group 1, and test group 2—so that the average weight of each group was approximately 26 g. Test group 1 consisted of obese model mice fed a diet containing the high-fat diet supplemented with 4% by weight of the bofutsushosan extract from Preparation Example 1 for 20 days. Test group 2 consisted of obese model mice fed a diet containing the high-fat diet supplemented with 4% by weight of the bofutsushosan extract from Preparation Example 2 for 20 days. The control group was fed a high-fat diet without the bofutsushosan extract for 20 days. Feces were collected every two days during the test period. The collected feces were freeze-dried.

[0043] Lipids were extracted from freeze-dried feces using a low-polarity solvent, and the total lipid content in the feces was measured by gravimetric analysis. Specifically, 100 mg of freeze-dried feces was crushed and weighed out, and extracted twice with 500 μL of chloroform / ethanol solution (chloroform:ethanol (volume ratio) = 2:1). This extract was vacuum dried at 30 °C, and the weight of the extract (lipid) was measured. The total lipid excretion amount for each group was calculated according to the following formula, and the total lipid excretion amount per mouse was calculated by dividing the total lipid excretion amount for each group by the number of mice in each group.

number

[0044] Furthermore, the extract (lipids) extracted from the feces excreted between 12 and 14 days after the start of the test was redissolved in isopropanol, and the weight of cholesterol was measured using a Cholesterol E Test Wako (Wako Pure Chemical Industries, Ltd.) according to the instructions included with the kit. The amount of cholesterol excreted in each group was calculated using the following formula, and the amount of cholesterol excreted per mouse was calculated by dividing the amount of cholesterol excreted in each group by the number of mice in each group.

number

[0045] The total lipid excretion amount per mouse in the control group was set to 100%, and the relative values ​​of the total lipid excretion amount per mouse in test groups 1 and 2 were calculated. Similarly, the cholesterol excretion amount per mouse in the control group was set to 100%, and the relative values ​​of the cholesterol excretion amount per mouse in test groups 1 and 2 were calculated.

[0046] The weight of each group of obese model mice was measured at the start of breeding (day 0) and on the final day of breeding (day 20). The weight at the start of breeding for each group was set as 100%, and the percentage of the weight on the final day of breeding was calculated as the weight change rate (%).

[0047] The results of total lipid excretion are shown in Table 3, the results of cholesterol excretion in Table 4, and the rate of change in body weight in Table 5.

[0048] [Table 3]

[0049] [Table 4]

[0050] [Table 5]

[0051] No diarrhea was observed in any of the mice during the breeding period. The daily fecal dry weight of each mouse ranged from 211.5 to 315.1 mg / day / mouse, with no significant difference observed between groups.

[0052] As can be seen from Table 3, in test groups 1 and 2 that received bofutsushosan extract powder containing 0.005 to 0.04 parts by weight of 6-gingerol per 100 parts by weight of the total amount of herbal ingredients, an increase in total lipid excretion was observed compared to the control group from day 6 onwards. There was no significant difference in the amount of dried feces between the groups, demonstrating that the intake of bofutsushosan extract powder increased the lipid concentration in the feces. In particular, from day 12 onwards, the amount of lipid excretion in test group 1 was greater than that in test group 2, demonstrating that the use of bofutsushosan extract powder (Production Example 1), which contains 0.010 parts by weight of 6-gingerol per 100 parts by weight of the total amount of herbal ingredients, enhanced the lipid excretion-promoting effect. In addition, a similar test was conducted on Bofutsushosan extract powder (6-gingerol content: 0.012 weight parts per 100 weight parts of Bofutsushosan extract powder (total amount of ingredients derived from herbs)) produced under the same conditions as in Production Example 1, except that the amount of ginger in the herbal preparation was 0.4 weight parts.It was found that the lipid excretion-promoting effect was greater than when the Bofutsushosan extract powder in Production Example 2 was used.

[0053] Furthermore, as is clear from Table 4, similar to the results for total lipid excretion, cholesterol excretion was increased compared to the control group in test groups 1 and 2 that had taken the bofutsushosan extract powders of production examples 1 and 2. Furthermore, cholesterol excretion was increased in test group 1 that had taken the bofutsushosan extract of production example 1 compared to test group 2 that had taken the bofutsushosan extract of production example 2.

[0054] Furthermore, as shown in Table 5, the control group showed an increase in body weight at the end of feeding compared to the start of feeding, whereas weight gain was suppressed in test groups 1 and 2 that had been given the bofutsushosan extracts of Production Examples 1 and 2. In particular, test group 1 that had been given the bofutsushosan extract of Production Example 1 showed a greater weight loss effect than test group 2 that had been given the bofutsushosan extract of Production Example 2. This suppression of weight gain by the bofutsushosan extract is thought to be partly due to its effect of promoting the excretion of lipids into the feces.

[0055] Test Example 2: Evaluation of the effect of reducing visceral fat and body weight Generation of a mouse model of early-life obesity Young mice (C57BL / 6J mice, 5 weeks old, male) were fed a high-fat diet (HFD32, CLEA Japan, Inc.) ad libitum for 4 weeks to create a juvenile obese mouse model.

[0056] In addition, age-related obesity model mice were generated by feeding aged mice (C57BL / 6J mice, 40-60 weeks old, male) ad libitum with a high-fat diet (HFD32, CLEA Japan, Inc.) for one week.

[0057] In addition, epididymal fat tissue was excised from three young obese and three aged obese model mice prepared as described above, and lipolytic activity was measured. Specifically, the excised adipose tissue from around the epididymis was washed with Krebs Ringer buffer (pH 7.4). After washing, the weight of the washed adipose tissue was measured, and 0.2 g of the washed adipose tissue was added to 5 mL of Krebs Ringer buffer (pH 7.4) containing 1 μg / mL noradrenaline and 2% by weight bovine serum albumin (BSA) and incubated at 37°C for 2 hours. The supernatant was then collected, and the amount of free fatty acids released into the supernatant in response to noradrenaline stimulation was measured using a NEFA-C Test Wako (Wako Pure Chemical Industries, Ltd.). The amount of free fatty acids released per gram of adipose tissue (mEq / g) was calculated as lipolytic activity.

[0058] Administration test of Bofutsushosan extract After measuring the body weight of the young obese model mice prepared above, they were divided into control group A (control example), test group A1, and test group A2 (6-11 mice per group) so that the average body weight of each group was approximately 26 g. In addition, after measuring the body weight of the age-related obesity model mice prepared above, they were divided into control group B (control example) and test group B (6 mice per group) so that the average body weight of each group was approximately 42 g.

[0059] Test group A1 was fed a feed containing 2% by weight of the bofutsushosan extract powder of Production Example 1 in the high-fat diet for 21 days. Test group A2 was fed a feed containing 4% by weight of the bofutsushosan extract powder of Production Example 1 in the high-fat diet for 21 days. Test group B was fed a feed containing 2% by weight of the bofutsushosan extract powder of Production Example 1 in the high-fat diet for 21 days. Control groups A and B were fed a high-fat diet not containing the bofutsushosan extract for 21 days. On the final day of the test, the body weight of each mouse was measured, and visceral fat was removed and measured.

[0060] The average weight of the mice in control group A on the final day of the test was set to 100%, and the relative values ​​of the average weight of the mice in test groups A1 and A2 on the final day of the test were calculated. In addition, the average weight of the mice in control group B on the final day of the test was set to 100%, and the relative values ​​of the average weight of the mice in test group B on the final day of the test were calculated. The average weight of the visceral fat of the mice in control group A on the final day of the test was set to 100%, and the relative values ​​of the average weight of the mice in test groups A1 and A2 on the final day of the test were calculated. The average weight of the visceral fat of the mice in control group B on the final day of the test was set to 100%, and the relative values ​​of the visceral fat weight of the mice in test group B on the final day of the test were calculated.

[0061] result The results obtained are shown in Table 6. The results show that bofutsushosan extract powder reduced body weight and visceral fat in both young obese model mice and age-related obese model mice, and in particular, in age-related obese model mice, feeding a diet containing 2% by weight of bofutsushosan extract powder reduced body weight and visceral fat to a greater extent than young obese model mice fed a diet containing 4% by weight of bofutsushosan extract powder.

[0062] Furthermore, the lipolytic capacity of the epididymal fat was 5.6mEq / g on average in the young obese model mice, while it was 0.28mEq / g in the age-related obese model mice, meaning that the lipolytic capacity decreased to one-twentieth of that in the old obese model mice with aging.It was an extremely unexpected result that Bofutsushosan extract powder effectively reduced body weight and visceral fat even in this age-related obese mouse model with a reduced lipolytic capacity.

[0063] [Table 6]

[0064] Test Example 3: Evaluation of weight reduction effects by age group The weight-reducing effect of bofutsushosan extract on people with a constitution that is inherently impaired in lipid decomposition and metabolic ability was evaluated. Specifically, nine men and women (selected so that the difference in average weight between each age group (20s, 30s, 40s-50s) was within 5 kg) who had a body fat percentage of 25% or more and a waist size of 85 cm or more for at least five years were administered 5000 mg of bofutsushosan extract powder from Preparation Example 1 three times a day for two weeks, and the change in weight compared to before the start of administration was measured.

[0065] The results are shown in Table 7. When people with a constitution that is inherently impaired in lipid degradation and metabolic ability were administered the bofutsushosan extract of Production Example 1, an average weight loss of approximately 1 kg was observed overall, and analysis by generation confirmed that the effect increased with age. In people in their 40s and 50s, lipid degradation and metabolic ability are inherently impaired, and it was previously thought that bofutsushosan extract would be ineffective in treating age-related obesity. However, as shown in Test Example 1 above, the bofutsushosan extract of Production Example 1 has an excellent effect of promoting lipid excretion in the feces, and this effect is thought to be one of the factors that contributed to the weight-reducing effect on age-related obesity.

[0066] [Table 7]

[0067] Prescription example Tablets (400 mg per tablet) containing bofutsushosan extract powder were prepared according to the formulations shown in Tables 8 to 13. The extract powder produced according to the above Production Example 1 or 2 was used as the bofutsushosan extract powder. All of the obtained tablets were expected to have the effect of promoting lipid excretion into feces.

[0068] [Table 8]

[0069] [Table 9]

[0070]

Table 10

[0071]

Table 11

[0072]

Table 12

[0073]

Table 13

Claims

1. A fecal lipid excretion promoter containing a bofutsushosan extract, wherein the bofutsushosan extract contains extracted 6-gingerol in an amount of 0.005 to 0.015 parts by weight per 100 parts by weight of a total amount of ingredients derived from herbal medicines, and the herbal medicine preparation used for extracting the bofutsushosan extract contains 2 to 3 parts by weight of ginger, calculated as anhydrous sodium sulfate, per 100 parts by weight of the herbal medicine preparation.

2. The fecal lipid excretion promoter according to claim 1 , which is taken continuously for six days or more.

3. 3. The fecal lipid excretion promoter according to claim 1 or 2, which is applied to a person who has had a body fat percentage of 25% or more and a waist size of 85 cm or more for 5 years or more.

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