Bofutsushosan 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 bofu-tsushosan extract which has an excellent effect of promoting the excretion of lipids into feces. [Background technology]

[0002] In recent years, with the Westernization of food culture, the amount of lipid intake by Japanese people has increased, and excessive lipid intake leads to weight gain and is a cause of obesity. The adverse effects of excessive lipid intake can be improved to some extent by increasing the lipid decomposition and metabolic ability in the body, but there is a limit to how much lipid decomposition and metabolic ability can be improved by taking medication. In particular, people who have a body fat percentage of 25% or more and a waist size of 85 cm or more for more than 5 years, and middle-aged and elderly people who have been obese for many years, have a constitution in which lipid decomposition and metabolic ability are essentially reduced, and it is considered difficult to improve lipid decomposition and metabolic ability for such people. Therefore, excreting lipids with feces to increase the amount of lipid excretion is useful for improving or avoiding health disorders caused by excessive lipid intake, and is considered to be effective in avoiding the adverse effects of lipid intake, especially for people with a constitution in which lipid decomposition and metabolic ability are essentially reduced.

[0003] On the other hand, Bofutsushosan is known as a herbal medicine that is effective in reducing visceral fat and improving metabolic syndrome. The mechanism of action of Bofutsushosan has also been revealed to be activation of heat production in brown fat cells via the sympathetic nervous system and promotion of fat decomposition in white fat cells (see Non-Patent Document 1). In addition, various formulations of Bofutsushosan extract have been developed from the viewpoints 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 feces. Also, people with constitutions that have an inherently decreased lipid decomposition and metabolic ability are not expected to benefit from improved lipid decomposition and metabolic ability, and so they do not usually take Bofutsushosan. [Prior art documents] [Non-patent literature]

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

[0006] [Patent Document 1] JP 2009-242354 A [Patent Document 2] JP 2009-242330 A Summary of the Invention [Problem to be solved by the invention]

[0007] The present inventors conducted an intensive search for components that promote the excretion of ingested lipids into the stool and discovered that Bofu-tsushosan extract has excellent effect of promoting the excretion of ingested lipids into the stool.

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

[0009] The present inventors have conducted extensive research to solve the above problems, and have found that when the bofutsushosan extract contains 0.005-0.04 parts by weight of 6-gingerol per 100 parts by weight of the total amount of ingredients derived from herbal medicines, the excretion-promoting effect of lipids in feces is improved. Furthermore, the present inventors have found that when the content of 6-gingerol is within the above range and the herbal medicine preparation used for extracting the bofutsushosan extract contains 2-6 parts by weight of Glauber's salt calculated as sodium sulfate per 100 parts by weight of the herbal medicine preparation, the excretion-promoting effect of the bofutsushosan extract is further improved. The present invention has been completed based on these findings and through further research.

[0010] That is, the present invention provides the following aspects. Item 1. Bofu-tsushosan 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 Bofu-tsushosan extract according to Item 1, wherein the herbal preparation used for extracting the Bofu-tsushosan extract contains 2 to 6 parts by weight of Bofu-tsushosan 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 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. Effect of the Invention

[0011] The Bofu-tsushosan extract of the present invention has a strong effect of promoting the excretion of ingested lipids in the stool, making it possible to effectively improve or avoid health problems caused by excessive lipid intake, even for people with a constitution that is essentially impaired in the ability to break down and metabolize lipids. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The bofu-tsushosan extract of the present invention is characterized in that it 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. 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 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, Saxifraga Root, Ephedra Root, Rhubarb, Bougainvillea Root, Byakujutsu Root, Platycodon Root, Scutellaria Root, Licorice Root, Scutellaria Root, and Glycyrrhiza Root. Some letters do not include Byakujutsu Root among the above herbal medicines (for example, "Kenken 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," edited by Osaka Yomiuri Shimbun, published by Naniwasha). The Bofutsushosan extract used in the present invention may be obtained from any of these Bofutsushosan, so long as the content of 6-gingerol falls within the specified range.

[0014] The bofu-tsushosan 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 the ingredients derived from the herbal medicine. 6-Gingerol is a component contained in ginger, and conventional bofu-tsushosan extracts usually contain 0.05 parts by weight or more of 6-gingerol per 100 parts by weight of the total amount of the ingredients derived from the herbal medicine. In the bofu-tsushosan extract of the present invention, the content of 6-gingerol is reduced to the above-mentioned range, so that it is possible to more effectively promote the excretion of lipids into the feces. From the viewpoint of more effectively promoting the excretion of lipids into the feces, the bofu-tsushosan extract contains preferably 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 the ingredients derived from the herbal medicine. Here, the ingredients derived from the herbal medicine are components extracted from the herbal medicines that constitute bofu-tsushosan. 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 place of origin and the number of years of growth of ginger, and the extraction efficiency of 6-gingerol from ginger also varies depending on the extraction conditions. Therefore, in order 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 in ginger. The amount of 6-gingerol extracted can be reduced by subjecting ginger to a processed product sliced ​​to a thickness of about 1 to 3 mm rather than to a product cut into thin strips of about 1 to 8 mm square and subjecting it to extraction, and a bofutsushosan extract containing 6-gingerol in the above ratio can be suitably obtained. For example, by setting the ratio of ginger per 100 weight parts of the total herbal preparation within the range shown in embodiment A described below, and then adjusting the shape of the ginger, a bofu-tsushosan extract containing 6-gingerol within the above-mentioned content range can be suitably obtained.

[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 Jihosha), "17th Revised Japanese Pharmacopoeia", etc., the amounts of each crude drug that makes up Bofu-tsusho-san are 1.2 parts by weight of Angelica Root, 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, 0.3 to 1.2 parts by weight of Zingiber Root, 1.2 parts by weight of Japanese Crown Root, 1.2 parts by weight of Bohu 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 Boswellia Root (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 Root, and 3 to 5 parts by weight of Polygala Root. In addition, some letters state that all of the 1.2 parts by weight listed above should be 1.5 parts by weight (for example, "Meikai Kampo Prescriptions," co-authored by Nishioka Kazuo and Takahashi Shintaro, published by Naniwasha Publishing).

[0017] The amount of each herb in the herb preparation used to manufacture Bofutsushosan extract is not particularly limited, so long as the content of 6-gingerol is within the above range, and each herb may be used in the amount shown in the example letter above, 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 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 Bofufu Root, 1.2 parts by weight of Ephedra Root, 1.2 parts by weight of Rhubarb, 1. 5 parts by weight, Boshou (in terms of anhydrous sodium sulfate) 0.6-1.5 parts by weight, Atractylodes Root 2 parts by weight, Platycodon Root 2 parts by weight, Scutellaria Root 2 parts by weight, Licorice Root 2 parts by weight, Gypsum Root 2-3 parts by weight (preferably 2 parts by weight), and Ginger Root 3-5 parts by weight (preferably 3 parts by weight), and Zingiber officinale 0.3-1.5 parts by weight, preferably 0.3-1.2 parts by weight, more preferably 0.3-0.4 parts by weight, and particularly preferably 0.3 parts by weight (hereinafter, sometimes referred to as "Mode A"). By adjusting the amount of Zingiber officinale in the herbal preparation used for the production of Bofu-tsushosan extract to fall within the above range, the content of 6-gingerol can be suitably satisfied within the above range, and the excretion of lipids into the feces can be more effectively promoted. In addition, in the present invention, "herbal medicine 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 specified amount of herbal medicines that make up Bofutsushosan.

[0018] In addition, as a preferred example of the above-mentioned aspect A, the amount of the lipid is 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, calculated as anhydrous sodium sulfate. By satisfying such a range of the amount of the lipid, it becomes possible to more effectively promote the excretion of lipids in feces. In the present invention, the amount of the lipid in anhydrous sodium sulfate refers to the conversion of the hydrate to an anhydrous weight when a hydrate of sodium sulfate is used as the lipid. As the lipid, a hydrate of sodium sulfate (e.g., decahydrate) and / or anhydrous sodium sulfate is used.

[0019] A suitable example of the herbal preparation used in the production of the bofu-tsushosan 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 the bofu-tsushosan extract from such a herbal preparation with a low ratio of ginger, the content of 6-gingerol can be suitably satisfied within the above range, and the excretion of lipids in the feces can be more effectively promoted.

[0020] A suitable example of the herbal preparation used in the production of the Bofu-tsushosan 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. By containing Boshou in such a ratio in the herbal preparation, it becomes possible to more effectively promote the excretion of lipids into the feces.

[0021] The bofutsushosan extract of the present invention can be obtained by extracting the herbal preparation by a known method. The method of extracting the herbal preparation may be the same as the conventional method of extracting the bofutsushosan extract, for example, a method of 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 to extract. After extraction, the solid content is removed by solid-liquid separation such as centrifugation and filtration, and if necessary, the bofutsushosan extract of the present invention is obtained by subjecting it to concentration treatment or drying treatment.

[0022] To obtain the Bofutsushosan extract of the present invention as an extract powder, the extract 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. When subjected to a drying process (particularly a drying process by spray drying), an excipient such as dextrin may be added to the extract as necessary. By adding an excipient in this way, it is 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 Bofu-tsushosan 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, a suitable adsorbent (e.g., silicic anhydride, starch, etc.) may be added to the soft extract to obtain an adsorbed powder.

[0024] The bofu-tsushosan 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 with the Bofutsushosan extract alone, 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 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 types of additives and bases used, the formulation form, etc.

[0026] In addition, the Bofutsushosan extract of the present invention may be formulated in combination with other nutritional components or pharmacological components as necessary. 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 according to the type of components used, the formulation form, and the like.

[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 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 the stability of the ingredients contained therein, portability, etc.

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

[0029] Purpose The Bofu-tsushosan extract of the present invention is used for weight loss, visceral fat reduction, etc., just like the conventional Bofu-tsushosan extract, but it has excellent effect of promoting the excretion of ingested lipids into feces, so it can be suitably used as a lipid excretion promoter in feces.In addition, the Bofu-tsushosan extract of the present invention has excellent effect of promoting the excretion of cholesterol into feces, so it can be suitably used for the purpose of promoting the excretion of ingested cholesterol or cholesterol in blood into feces.

[0030] In addition, for people with a constitution that is essentially reduced in lipid decomposition and metabolism, the conventional Bofutsushosan extract is not expected to improve lipid decomposition and metabolism, and is not believed to be able to achieve weight loss or visceral fat reduction, and so there has been no custom of taking the conventional Bofutsushosan extract. However, the Bofutsushosan extract of the present invention can promote the excretion of lipids in 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 that is essentially reduced in lipid decomposition and metabolism. In view of the effects of the present invention, the Bofutsushosan extract of the present invention is preferably applicable to people with a constitution that is essentially reduced in lipid decomposition and metabolism. Specific examples of people with such a constitution include those who have had a body fat percentage of 25% or more and a waist size of 85 cm or more for more than 5 years; middle-aged or older people (45 years or older) who are obese (e.g., a body fat percentage of 25% or more); and those who have adipose tissue with a lipolytic power of 5mEq / g or less, preferably 3mEq / g or less, more preferably 1mEq / g or less, even more preferably 0.5mEq / g or less, and particularly preferably 0.3mEq / g or less, as measured in the lipolytic power evaluation test described below. <Fat decomposition ability evaluation test> First, adipose tissue is collected from the subcutaneous tissue of a subject. The obtained adipose tissue is washed with Krebs Ringer buffer (pH 7.4). The weight of the washed adipose tissue is measured, and 5 mL of Krebs Ringer buffer (pH 7.4) containing 1 μg / mL noradrenaline and 2% by weight bovine serum albumin (BSA) is added to 0.2 g of the washed adipose tissue, and incubated at 37°C for 2 hours. The supernatant is then collected, and the amount of free fatty acids released into the supernatant by noradrenaline stimulation is measured, and the amount of free fatty acids released per 1 g of adipose tissue (mEq / g) is calculated as the lipolysis power.

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

[0032] Dosage / Usage The bofutsushosan extract of the present invention is used by oral administration. The dosage of the bofutsushosan extract of the present invention is appropriately set according to the age, sex, constitution, etc. of the recipient, but for example, the total amount of the herbal medicine-derived components of 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, and may be taken 1 to 3 times a day, preferably 2 or 3 times a day. The timing of taking the extract 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).

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

[0034] The present invention will be described in more detail 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 herb shown in Table 1 was chopped or sliced, mixed in the specified amounts, and chopped to obtain a herb preparation. Water was added to the herb preparation in an amount 20 times by weight, 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.

[0036] In Production Examples 1 and 2, ginger was used that was cut into 1-8 mm cubes, while ginger was used in slices having a thickness of 1-3 mm in Production Example 3. Drying with 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 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 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 quantitative analysis 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 were accurately taken and 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 be 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 in which the ratio of ginger was as low as 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). In addition, 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 it was cut 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 Mice (C57BL / 6J mice, 5 weeks old, male) were fed 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 (control example), test group 1, and test group 2 (6 to 11 mice per group), so that the average weight of each group was about 26 g. In test group 1, the obese model mice were fed a feed in which the high-fat diet was mixed with 4% by weight of the bofutsushosan extract of Production Example 1 for 20 days. In test group 2, the obese model mice were fed a feed in which the high-fat diet was mixed with 4% by weight of the bofutsushosan extract of Production Example 2 for 20 days. In the control group, the high-fat diet not containing the bofutsushosan extract was fed for 20 days. Feces were collected every two days during the test period. The collected feces were freeze-dried.

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

number

[0044] Furthermore, the extracts (lipids) extracted from the feces excreted between 12 and 14 days after the start of the test were 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 calculation 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 the 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 the test groups 1 and 2 were calculated.

[0046] In addition, the weight of the obese model mice in each group 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 mass of each mouse was 211.5-315.1 mg / day / mouse in dry weight, with no significant difference between groups.

[0052] As can be seen from Table 3, in test groups 1 and 2 that were administered Bofutsushosan extract powder with a 6-gingerol content of 0.005 to 0.04 parts by weight per 100 parts by weight of the total amount of ingredients derived from herbal medicines, an increase in the total lipid excretion was observed compared to the control group from the 6th day of rearing. Since there was no significant difference in the amount of dry feces between the groups, it was revealed that the lipid concentration in the feces was increased by administering Bofutsushosan extract powder. In particular, from the 12th day of rearing, the lipid excretion amount in test group 1 was greater than that in test group 2, and it was revealed that the use of Bofutsushosan extract powder (Production Example 1) with a 6-gingerol content of 0.010 parts by weight per 100 parts by weight of the total amount of ingredients derived from herbal medicines enhances the lipid excretion promoting effect. In addition, a similar test was conducted on Bofutsushosan extract powder (6-gingerol content: 0.012 parts by weight per 100 parts by weight of Bofutsushosan extract powder (total amount of herbal ingredients)) produced under the same conditions as in Production Example 1, except that the amount of ginger in the herbal preparation was 0.4 parts by weight.It was found that the lipid excretion-promoting effect was greater than when the Bofutsushosan extract powder of Production Example 2 was used.

[0053] 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 which had been administered the bofutsushosan extract powders of Production Examples 1 and 2. Furthermore, cholesterol excretion was increased in test group 1 which had been administered the bofutsushosan extract of Production Example 1 compared to test group 2 which had been administered the bofutsushosan extract of Production Example 2.

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

[0055] Test Example 2: Evaluation of the effect of reducing visceral fat and body weight Generation of juvenile obese mouse models 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 was removed from three young obese model mice and three aged obese model mice prepared above, and lipolytic power was measured. Specifically, the adipose tissue removed from the epididymis was washed with Krebs Ringer buffer (pH 7.4). The weight of the adipose tissue after washing was measured, and 5 mL of Krebs Ringer buffer (pH 7.4) containing 1 μg / mL noradrenaline and 2 wt% bovine serum albumin (BSA) was added to 0.2 g of the washed adipose tissue, and incubated at 37 ° C for 2 hours. The supernatant was then collected, and the amount of free fatty acid released into the supernatant by noradrenaline stimulation was measured using NEFA-C Test Wako (Wako Pure Chemical Industries, Ltd.), and the amount of free fatty acid released per 1 g of adipose tissue (mEq / g) was calculated as lipolytic power.

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

[0059] Test group A1 was fed a feed in which the bofutsushosan extract powder of Production Example 1 was mixed with the high-fat diet at 2% by weight for 21 days. Test group A2 was fed a feed in which the bofutsushosan extract powder of Production Example 1 was mixed with the high-fat diet at 4% by weight for 21 days. Test group B was fed a feed in which the bofutsushosan extract powder of Production Example 1 was mixed with the high-fat diet at 2% by weight for 21 days. Control groups A and B were fed a high-fat diet without 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 the weight was measured.

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

[0061] result The results are shown in Table 6. From these results, it was confirmed that the bofutsushosan extract powder reduced body weight and visceral fat in both the juvenile obesity model mice and the age-related obesity model mice, and in particular, in the age-related obesity model mice, feeding a diet containing 2% by weight of bofutsushosan extract powder reduced body weight and visceral fat more than the juvenile obesity model mice fed a diet containing 4% by weight of bofutsushosan extract powder.

[0062] 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 aged obese model mice, and the lipolytic capacity decreased to one-twentieth of that in the old obese model mice with aging. It was an unexpected result that Bofutsushosan extract powder effectively reduced body weight and visceral fat even in the old obese mouse model with reduced lipolytic capacity.

[0063] [Table 6]

[0064] Test Example 3: Evaluation of weight loss effects by age group The weight-reducing effect of Bofutsushosan extract on people with a constitution that is essentially impaired in lipid decomposition and metabolism was evaluated. Specifically, 9 men and women (selected so that the difference in average weight between each age group (20s, 30s, 40s to 50s) who had a body fat rate of 25% or more and a waist size of 85 cm or more for 5 years or more) were administered 5,000 mg of Bofutsushosan extract powder of Preparation Example 1 three times a day for 2 weeks, and the change in weight compared to before the start of administration was measured.

[0065] The results are shown in Table 7. When the bofutsushosan extract of Production Example 1 was administered to people with a constitution in which lipid decomposition and metabolic ability were essentially decreased, a weight loss of about 1 kg was observed on average overall, and when analyzed by generation, it was confirmed that the effect increases with age. In age-related obesity in people in their 40s and 50s, lipid decomposition and metabolic ability are essentially decreased, and it was previously thought that bofutsushosan extract would not be effective, but the bofutsushosan extract of Production Example 1 has an excellent effect of promoting lipid excretion into feces as shown in the above-mentioned Test Example 1, and it is believed that this effect is one of the factors that contributed to the weight loss effect on age-related obesity.

[0066] [Table 7]

[0067] Prescription Examples 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-mentioned 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 0.007 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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